Contains Nonbinding Recommendations
Surveying, Leveling, and 
Alignment
Laser Products
Guidance for Industry and
Food and Drug Administration Staff
Document issued on January 31, 2023.
The draft of this document was issued on May 5, 2014.
For questions regarding this document contact the Office of Health Technology 8 (OHT8): Office 
of Radiological Health at RadHealth@fda.hhs.gov. 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health  Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and 
Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify 
all comments with the docket number FDA-2014-D-0435. Comments may not be acted upon by 
the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 1764 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I. Introduction ........................................................................................................................................... 1
II. Background   ............................................................................................................................................ 2
III. Scope ................................................................................................................................................. 2
IV. Questions and Answers ..................................................................................................................... 2 Contains Nonbinding Recommendations
Surveying, Leveling, and Alignment 
Laser Products
Guidance for Industry and Food 
and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or 
the public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff or Office 
responsible for this guidance as listed on the title page. 
I.  Introduction
This guidance is intended for manufacturers of laser products and outlines the Food and Drug 
Administrations (FDAs or the Agencys) approach regarding the applicability of FDAs 
performance standard regulations to surveying, leveling, and alignment (SLA) laser products.
The topics that are addressed include:
 The definition of an SLA laser product
 Considerations for what is an SLA laser product
 Examples of SLA and non-SLA laser products
 SLA laser product class limits 
 Requesting a variance or exemption from SLA laser product class limits
In general, FDA guidance documents do not establish legally enforceable responsibilities. Instead, 
guidances describe the Agencys current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited. The use of the 
word should in Agency guidances means that something is suggested or recommended, but not 
required.
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II.  Background 
FDA regulates radiation-emitting electronic products, including all types of lasers. The Agency 
sets radiation safety product performance standards that must be met by manufacturers in order 
for laser products to be legally sold in the U.S. market. 
III.  Scope
This guidance is intended to summarize FDAs current thinking on the applicability of FDAs 
performance standards for laser products to specific purpose SLA laser products. This guidance 
is not intended to serve as a replacement for the performance standards themselves.
IV.  Questions and Answers
A.  Question: What is an SLA laser product?
Answer: An SLA laser product is defined in 21 CFR 1040.10(b)(39) as a laser product 
manufactured, designed, intended or promoted for one or more of the following uses:
(i)  Determining and delineating the form, extent, or position of a point, body, or area by 
taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another. 
(iii) Defining a plane, level, elevation, or straight line.
SLA laser products are designed to transmit laser radiation through open space for measuring 
and positioning purposes and SLA laser product class limits at 21 CFR 1040.11(b) are 
intended to impose appropriate upper limits on the accessible laser emission from such 
products consistent with their intended function and the generally unrestricted environments in 
which they are used.1
Be aware that promotion of a multi-use laser product for other, non-SLA laser product uses 
does not remove the product from the SLA laser product definition or class limits, or allow 
alternative class specific limits to be applied in lieu of the SLA laser product class limits, as 
long as the laser product is manufactured, designed, intended, or promoted for one or more 
SLA uses.  
B.  Question: What does FDA consider as transmission of laser radiation through open 
space?  
Answer:  SLA laser product class limits apply to products defined in 21 CFR 1040.10(b)(39), 
1 See 38 FR 34084, 34085 (December 10, 1973).
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which are designed to transmit laser radiation through open space. FDA considers transmission 
through open space generally as transmission through any space where a person may be 
exposed directly or indirectly to the laser radiation. Transmission of laser radiation outside of a 
protective housing or optical fiber would be considered as transmission through open space. 
C.  Question: What design factors should manufacturers consider when determining 
whether their product is an SLA laser product?
Answer:  Manufacturers should consider whether the product design can transmit laser 
radiation through open space for any of the purposes outlined in 21 CFR 1040.10(b)(39). Any 
laser product manufactured, designed, intended, or promoted to transmit laser radiation 
through open space outside a protective housing for a surveying, leveling, or alignment use 
would be considered an SLA laser product, regardless of the light characteristics of the laser 
beam (e.g., illumination, divergence, visibility, whether it is focused on a directed area). Thus, 
for example, a laser product designed to align the orientation of machinery or parts of a 
manufacturing process, or to define a straight line to a specific target would be an SLA laser 
product, regardless of the light characteristics of the laser beam. FDA would consider design 
features that allow the laser product to be portable (e.g., handheld, battery operated) and 
transmit through open space (e.g., lacking features for a protective housing or optical fiber 
connections) to be factors supporting that the product is manufactured, designed, or intended 
for SLA laser product purposes. See Question H for examples of SLA laser products.
D.  Question: Do SLA laser product class limits apply to any laser product that is designed to 
transmit laser radiation through open space?
Answer:  No. Not all laser products that are designed to transmit laser radiation through open 
space are considered to be SLA laser products. If the laser product is not manufactured, 
designed, intended, or promoted for one or more of the uses identified in 21 CFR 
1040.10(b)(39), it would not be considered an SLA laser product and the SLA laser product 
class limits would not apply. Please see Question G for examples of products that FDA does 
not consider to be SLA laser products. 
E. Question: What intended use and promotion factors should manufacturers consider 
when determining whether their product is an SLA laser product?
Answer:  The design of a laser product should support its intended use. The intended use is 
determined, for example, based on the manufacturers written or oral expressions, including, 
but not limited to, the content of the product labels and product description contained in the 
user or service instructions as well as any promotional materials, product catalogues, 
specification sheets, product websites or demonstrations of how the product should be used 
and for what purposes.  
Promotion of a product that meets the definition of an SLA laser product for non-SLA general 
or research purposes, or promotion for sale only to certain types of purchasers does not relieve 
the manufacturer from complying with the SLA laser product class limits or obtaining a 
3 Contains Nonbinding Recommendations
variance from FDA if the product exceeds the SLA laser product class limits.
Manufacturers of SLA laser products are responsible for complying with the applicable class 
limits and cannot avoid that responsibility by issuing a disclaimer. If the manufacture, design, 
intended use, or promotion of a laser product causes it to meet the definition of an SLA laser 
product, then a disclaimer would not be considered sufficient to comply with the regulations or 
protect the public from a laser exposure that exceeds the SLA laser product class limits.
F. Question: Are general purpose laser products or laser products for laboratory research 
considered to be SLA laser products? 
Answer:  Laser products that are manufactured, designed, intended, and promoted only as 
general purpose laser light sources or for laboratory research purposes such as fluorescence-
based applications, flow cytometry, confocal microscopy, and multi-array readers, or for bench 
research purposes (e.g., laser sources for an optical physics laboratory) are not considered to be 
SLA laser products. 
By design, these products typically utilize power solely from a corded, hard-wired electrical 
source that terminates in a connector or plugs into to a non-battery power source. The design 
typically facilitates fixture onto an optical bench or protective housing. Such laser products 
may be of a size which could lend themselves to be used for, e.g., pointing or alignment 
purposes; however, FDA would not consider the laser to be an SLA product if other aspects, 
such as whether it transmits laser radiation through open space, do not suggest it is 
manufactured, designed, intended, or promoted for an SLA laser product purpose.
G. Question: What are examples of products that are not SLA laser products?
Answer:
(1)  Laser guide star  is artificially created by transmitting laser radiation through open 
space into the atmosphere. The purpose is to interact with sodium atoms creating a glow 
in the upper atmosphere or to produce molecular light scatter in lower regions of the 
atmosphere. This scatter serves as a wavefront reference for adaptive optics used on 
ground-based space telescopes to compensate for atmospheric distortion of light. It is 
manufactured, designed, intended, and promoted to provide data for adaptive optics, not 
for an SLA laser product purpose. Although the laser radiation is being transmitted 
through open space, the product generally would not be manufactured, designed, 
intended, or promoted for an SLA use if, as would normally be the case for this type of 
laser, the laser radiation and product cannot be used in determining and delineating the 
form, extent, or position of a point, body, or area by taking angular measurement, 
positioning or adjusting parts in proper relation to one another, or defining a plane, level, 
elevation, or straight line. 
(2)  Remote-sensing lasers  transmit laser radiation through open spaces and do not have a 
surveying, leveling, or alignment use. These laser products may measure gases from a 
distant location, such as from ground positions or airborne platforms through analysis of 
reflected signals following emission of laser light at specific wavelengths.  Although the 
4 Contains Nonbinding Recommendations
laser radiation is being transmitted through open space, the product generally would not 
be manufactured, designed, intended, or promoted for an SLA use if, as would normally 
be the case for this type of laser, the laser radiation and product cannot be used in 
determining and delineating the form, extent, or position of a point, body, or area by 
taking angular measurement, positioning or adjusting parts in proper relation to one 
another, or defining a plane, level, elevation, or straight line. 
(3)  Communication or Energy transmission lasers  transmit laser radiation for the 
purpose of sending and receiving data or power through open space rather than through 
fiber optics or another solid medium. These are considered to be outside the scope of 
SLA uses. The transmission of the laser light would be controlled based on the input 
signal (e.g., communications cable), and not include other functionality that would 
constitute an SLA use.  Although the laser radiation is being transmitted through open 
space, the product generally would not be manufactured, designed, intended, or promoted 
for an SLA use if, as would normally be the case for this type of laser, the laser radiation 
and product cannot be used in determining and delineating the form, extent, or position 
of a point, body, or area by taking angular measurement, positioning or adjusting parts in 
proper relation to one another, or defining a plane, level, elevation, or straight line.
(4)  General purpose laser products or laser products for laboratory research as 
indicated in Question F.
For non-SLA laser products that utilize laser emissions in open space environments, we note 
that, among other requirements, 21 CFR 1040.10(f)(1) requires manufacturers to have a 
protective housing that prevents human access during operation to laser and collateral radiation 
that exceed the limits of Class I and table VI, respectively, wherever and whenever such 
human access is not necessary for the product to perform its intended function. Wherever and 
whenever levels that exceed these limits are necessary, these levels shall not exceed the limits 
of the lowest class necessary to perform the intended function(s) of the product. 
H.  Question: What are examples of SLA laser products?
Answer: Examples of products that FDA is aware of that are manufactured, designed, 
intended, or promoted for one or more of the uses listed in 21 CFR 1040.10(b)(39) include but 
are not limited to the following products, all of which are designed to transmit laser radiation 
through open space:
(1)  Laser pointers2  ergonomically hand-held, portable, battery powered laser products that 
are designed for transmitting laser radiation in a straight line. These products may be 
promoted for a variety of purposes such as high intensity focus and heating, avian 
control, and as pet toys. By the way they are designed, they are considered SLA products.
(2)  Levels and tools that incorporate laser guides  typically portable, battery powered 
laser products manufactured, designed, intended, or promoted for positioning parts in 
relation to each other, or defining a plane, level, elevation, or straight line in construction 
trades or for home use; they are also sometimes integrated into other tools, such as power 
2 Some laser pointers may be demonstration laser products, as defined in 21 CFR 1040.10(b)(13), if they are manufactured, 
designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition. 
Laser pointers are subject to the same class limits regardless of whether they are classified as SLA laser products or 
demonstration laser products. See 21 CFR 1040.11(b) and (c).
5 Contains Nonbinding Recommendations
tools that define a plane, line, or point to guide cutting or drilling. 
(3)  Machine vision structured light lasers  generate lines, point, or bar patterns to 
determine data based on known angles and apply trigonometry on a point-by-point basis 
to generate a three-dimensional data set or point-cloud of a form or object. These are 
used to measure contours and delineate the form, extent, or shapes of objects or people 
by taking an angular measurement.
(4)  Gun sights  portable, battery powered laser products mounted on various guns for 
transmitting laser radiation in a straight line for aligning the path of a ballistic projectile 
toward a target.
(5)  Target designators  may be ergonomically hand-held or mounted, portable, battery 
powered laser products or integrated into a targeting system that fires ordinances. These 
products are for identifying a target or for aiming a projectile or ordinance at a target by 
defining a straight line.  
(6)  Night vision illuminators  products that are designed for aiming or targeting at night by 
transmitting laser radiation in a straight line that is visible using night vision goggles. 
These products are typically promoted for these purposes and may be a standalone unit, a 
unit mounted onto another product, or integrated into another product such as a weapon, 
optics such as binoculars or telescopes, surveillance cameras, or other surveillance/target 
designator systems. 
(7)  Visual disruptors  may be portable handheld or fixed designs. These products may be 
manufactured, designed, intended, or promoted for illumination of a human target at a 
defined position in a straight line from the laser to a person to disrupt vision. FDA 
considers a visual disruptor to be an SLA laser to the extent it could be used for aiming a 
beam, projectile, or ordinance at a target by defining a straight line (e.g., laser-based 
target designators, laser night vision illuminators, laser-based gun sights), akin to a 
gunsight or target designator. Some disruptors have settings for adjustment of beam 
characteristics allowing use in different applications. If the disruptor can be utilized as an 
SLA laser under any of its settings, then the disruptor would meet the definition of an 
SLA laser product.
(8)    Alignment lasers  are manufactured, designed, intended, or promoted to align or 
position laser light, moving/fixed objects or structures in relation to each other, or take a 
measurement by angular positioning. These products may also be used to determine 
when a particular group of objects or structures are out of a specified position. 
(9)  LIDAR (Light Detection and Ranging) lasers  These products may emit laser 
radiation specifically to perform distance measurement and survey or map areas by 
taking angular measurements. The products would be utilized for an SLA purpose when 
surveying or mapping, such as by taking angular and distance measurements of multiple 
points to delineate the form or extent of a region. Accordingly, LIDAR products may be 
considered SLA laser products. However, the preamble to the performance standard in 
the Federal Register states [i]mposition of the requirements of 1040.11(b) on distance 
measurement laser products is not appropriate since substantially higher powers and 
different beam configurations are required for ranging purposes.3 A laser that is solely 
manufactured, designed, intended and promoted as a LIDAR laser for distance 
measurement for ranging purposes is not class limited under 21 CFR 1040.11(b). 
Regarding the safety of LIDAR laser products, they remain subject to the requirements of 
21 CFR 1040.10, including that the scanned portion of the laser emission from a LIDAR 
3 See 39 FR 32098 (September 4, 1974).
6 Contains Nonbinding Recommendations
is subject to the scanning safeguard provision of the performance standard under 21 CFR 
1040.10(f)(9). Any non-scanned radiation from a LIDAR or rangefinder should be as low 
as reasonably achievable to prevent inadvertent hazardous exposures or cause the 
disruption of vision.
The above-described laser products have design and manufacturing features that allow them to 
transmit laser radiation through open spaces for SLA laser purposes, such as to delineate a 
point or form by taking an angular measurement, position parts in relation to one another, or 
define a plane, level, elevation, or straight line.   
To the extent that an SLA laser product exceeds the class limits, such product manufacturers 
should determine whether the SLA laser product cannot achieve its purpose without emitting 
laser radiation that exceeds the SLA laser product class limit. If this is the case, the 
manufacturer should submit a variance application to FDA under 21 CFR 1010.4 that explains 
how an alternative suitable means of protection will be provided.  For more information about 
variances, please see Question L.
I. Question: Do SLA laser product class limits apply to laser products intended for use as 
components?
Answer:  If laser products that are intended for use as components (LPAC) of electronic 
products meet the criteria for exception from the performance standard at 21 CFR 1040.10(a), 
then SLA laser product class limits do not apply.  The finished laser product manufacturer will 
be responsible for compliance with the performance standard, including SLA laser product 
class limits as applicable. LPACs subject to the performance standard must be certified. See 21 
CFR 1010.2. 
If an SLA laser product is sold in a kit form, as a collection of parts, part bundles, labels, and 
assembly and user instructions, then the laser performance standard requirements apply when 
the laser is properly assembled, including instructions for assembly and use and labels. See the 
guidance Manufacture and Certification of Laser Kits, 21 CFR 1040.10 and 1010.2 (Laser 
Notice 13).4
J.    Question: What are the SLA laser product class limits?
Answer:  21 CFR 1040.11(b) states that SLA laser products must comply with all applicable 
requirements of 21 CFR 1040.10 for a Class I, IIa, II, or IIIa laser product, and are not allowed 
to permit human access to laser radiation in excess of the accessible emission limits of Class 
IIIa. As a result, this regulation establishes an upper class limit of Class IIIa, which has an 
accessible emission limit of 5 milliwatts, for visible wavelengths. SLA laser products that emit 
invisible radiation (wavelengths up to and including 400 nanometers and wavelengths higher 
than 710 nanometers) may not exceed the accessible emission limits for Class I, because 
Classes IIa, II, and IIIa do not include wavelengths outside the visible range.  
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacture-and-certification-
laser-kits-laser-notice-13. 
7 Contains Nonbinding Recommendations
FDA does not intend to object to SLA laser product emissions that are within the accessible 
emission limits for Classes 1, 2, and 3R in the International Electrotechnical Commission 
(IEC) International Standard 60825-1, Safety of laser Products  Part 1: Equipment 
classification and requirements, Ed. 1.2, 2.0, or 3.0 (IEC 60825-1). This is because FDA 
considers the IEC limits to be sufficiently comparable to the class limits for SLA laser products 
in FDA regulations to adequately assure safety. FDA does not consider conformance to the 
parameters for IEC Classes 1M or 2M to be equivalent to FDA performance standards because 
IEC Classes 1M and 2M do not have comparable analogs in FDAs classification system.
The properties of laser light make its emission highly directional. Collimated laser light 
maintains its power density over long distances. These properties are highly suitable for SLA 
laser product uses, but also present hazards to the public when transmitted through open space 
in unrestricted environments. 
The SLA laser product class limits at 21 CFR 1040.11(b) are intended to impose appropriate 
upper limits on the accessible laser emissions from such products consistent with their 
intended function and the generally unrestricted environments in which they often are intended 
to be used. The SLA laser product class limits consider the normal human aversion reflex 
(blinking or turning away) that would occur and reduce the hazard from accidental exposure to 
visible laser light. The SLA laser product class limits also reduce the hazard from exposure to 
invisible laser light, when the aversion reflex is not effective.
K.  Question: Would an SLA laser product that exceeds the SLA laser product class limits 
be considered compliant if a manufacturer incorporates the Class IIIb or IV laser 
performance requirements?
Answer:  No. SLA class limits under 21 CFR 1040.11(b) apply to SLA products, unless an 
exception in 21 CFR 1040.10(a) applies, or FDA has approved a variance under 21 CFR 
1010.4 or an exemption under 21 CFR 1010.5 that permits the class limits to be exceeded 
under certain conditions.
For SLA laser products that exceed SLA class limits, even when other class-specific 
performance requirements in the laser performance standard are met, manufacturers must still 
apply for a variance or exemption from the applicable class limits in 21 CFR 1040.11(b). 
Class-specific performance standard requirements found in 21 CFR 1040.10(f-h) are 
insufficiently effective in reducing the hazard of unexpected exposure to laser radiation in 
open space above laser class IIIa levels. For these reasons, class-specific performance 
standards are seldom a condition of a variance or exemption approval.
L.  Question:  What should a manufacturer do if their product needs to exceed the SLA 
laser class limits in 21 CFR 1040.11(b) to achieve its intended purpose?
Answer:  If a manufacturer wishes to enter commerce with an SLA laser product that needs to 
exceed the class limits in 21 CFR 1040.11(b) to achieve its intended purpose, then the 
manufacturer should review the criteria for qualifying for issuance of a variance as described in 
21 CFR 1010.4(a) and the information required to be included in a variance application (see 21 
8 Contains Nonbinding Recommendations
CFR 1010.4(b)).  FDA may issue a variance if these criteria are met, including an FDA 
determination that:
i.  The product utilizes an alternate means for providing radiation safety or protection 
equal to or greater than that provided by products meeting all requirements of the 
applicable standard, or
ii.  The product performs a function or is intended for a purpose which could not be 
performed or accomplished if required to meet the applicable standards, and 
suitable means for assuring radiation safety or protection are provided, or
iii.  One or more requirements of the applicable standard are not appropriate, and 
suitable means for assuring radiation safety or protection are provided.5
As described in 21 CFR 1010.5, if an SLA laser product is intended for United States 
Government use, either the manufacturer or the U.S. department or agency may apply for an 
exemption from portions of the performance standard; a manufacturer may distribute directly 
to a U.S. department or agency that currently holds an exemption with conditions allowing the 
distribution.6
M. Question: What are the typical requirements and conditions of an approved variance or 
exemption for SLA laser products that exceed the SLA laser class limits?
Answer: The requirements and conditions that would be needed for an individual variance or 
exemption are established on a case-by-case basis and tailored to provide appropriate levels of 
radiation safety protection based on the specific product design and intended use.  
We encourage manufacturers to contact FDA with a proposed set of suitable alternative means 
of assuring radiation safety or protection prior to submitting an application for a variance or 
exemption. FDA will review the application to determine what design, installation, and/or 
other controls would be suitable. While FDA considers both engineering controls and 
administrative controls in variance applications, we recommend manufacturers use engineering 
controls as the primary form of emission control whenever possible.
Examples of engineering controls may include, but are not limited to:
 Use of interlock connections utilizing altitude monitoring and ground sensing systems 
for aircraft to limit unsafe levels of exposure to an unprotected person at ground level;
 Use of range-finding sensors or other instruments to monitor distances from the laser 
5 See 21 CFR 1010.4(a)(2).
6 On July 29, 1976, FDA exempted laser products that are used exclusively by Department of Defense components and 
that are designed for actual combat or combat training operations or are classified in the interest of national security from 
the requirements of 21 CFR 1040.10 and 1040.11.  This exemption can be viewed on pages 30-32 of the document 
EXEMPTIONS From Electronic Product Regulations: A Compilation of Exemptions for Electronic Products Found in 21 
CFR Chapter I, Sub-Chapter J --Radiological Health Parts 1000  1050 (https://www.fda.gov/media/78277/download).  
Clarification on the exemption was provided in FDA guidance Guidance on the Department of Defense Exemption from 
the FDA Performance Standard for Laser Products (https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-department-defense-exemption-fda-performance-standard-laser-products).
9 Contains Nonbinding Recommendations
to a potential individual; and/or
 Derating the lasers power or cutting its power when individuals approach the nominal 
ocular hazard distance of the laser.
Examples of administrative controls include, but are not limited to:
 Restriction of sales to certain types of purchasers, such as restricting sales only to 
federal, state, and local law enforcement or other agencies;
 Training users on how to safely use the product, using log books or other means to 
document the training, and
 Limiting use of the product to restricted environments, solely where the products 
emission cannot be publicly accessible.
FDA considers a generally unrestricted environment to be any environment where a person 
untrained or unprotected from laser emissions could be present. Examples of generally 
unrestricted environments include:
 Any type of residence or residential property;  
 Public areas within a commercial building;
 Any area of a workplace where employees are unprotected from unsafe exposure to 
laser emissions; or
 Any public place where people could be expected to purposely or accidently be 
exposed to the laser emission.
10