CDRH Final Guidance 2-Page Cover Sheet
Guidance for Industry
Slit Lamp Guidance
Document issued on: July 8, 1998
U.S. Department Of Health And Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Diagnostic and Surgical Devices Branch
Division of Ophthalmic Devices
Office of Device Evaluation Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to,
Division of Ophthalmic Devices, HFZ-460, 9200 Corporate Blvd, Rockville, MD  20850.
Comments may not be acted upon by the Agency until the document is next revised or
updated.  For questions regarding the use or interpretation of this guidance contact
Everette T. Beers, Ph.D. at 301/594-2018.
Additional Copies
World Wide Web/CDRH home page:  http://www.fda.gov/cdrh or CDRH Facts on
Demand at 1-800-899-0381 or 301-827-0111, specify number 1242 when prompted for
the document shelf number. Division  of
1
Slit Lamp Guidance
Version 1.0
                                     
Ophthalmic Devices
I. Device Description
Common Name: AC-Powered Slitlamp Biomicroscope
Class: II
Classification Panel: 86
Product Code: HJO
Regulation Number: 886.1850
Description: An AC-powered slitlamp biomicroscope is an AC-powered device that is a
microscope intended for use in eye examination that projects into the
patients eye through a control diaphragm a thin, intense beam of light.
Inclusions/Exclusions:  Including all accessories.
II. Indication for Use
An AC-powered slitlamp biomicroscope is intended for use in eye examination of the
anterior eye segment, from the cornea epithelium to the posterior capsule.  It is used to aid
in the diagnosis of diseases or trauma which affect the structural properties of the anterior
eye segment.
________________________________________
1 This document is intended to provide guidance.  It represents the Agencys current thinking on
the above.  It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public.  An alternative approach may be used if such approach satisfies the
requirements of the applicable statue, regulations, or both. Page 2 - Slit Lamp Guidance
III. Required 510(k) Information
Device Trade or Proprietary Name
Device Common or Usual Name
Establishment Registration Number (if establishment registered)
Class
Classification Panel
Action taken to comply with Section 514 of the Act
Proposed labels, labeling, and Advertisements (if available) which describe the device, its
intended use, and directions for use
Truthful and Accurate Statement
510(k) Statement or Summary
Indications for Use Form
The Marketed Device(s) to which equivalence is claimed including labeling and
description of the device(s) and 510(k) number(s), if known.
Statement, table or chart of similarities and differences with Marketed Device(s)
IV. Additional Information Required Under 21 CFR 807.87(h)
Submitters Name and Address
Contact Person, Telephone and Fax Number
Table of Contents with Pagination
Address of Manufacturing Facility/Facilities, and Sterilization Facility (if appropriate)
V. Information Specific for this Device
A. Materials: No flammable materials may be near the light source.
B. General Equivalency:   For purposes of the 510(k) notification, provide a side-by-side
comparison of the device with the predicate, noting similarities and explaining any
differences, for the following items:
1.  intended uses;
2.  method of operation;
3.  exposure parameters;
4.  data collection and/or display systems;
5.  flammability of materials;
6.  maximum temperature of parts of the device held by the operator or accessible to the Page 3 - Slit Lamp Guidance
patient; and,
7. brightness controls.
C. Optical Equivalency and Radiation Safety:  Slit lamps using Class 1 lasers are exempt
from this requirement.  In addition to the above, establish equivalent effectiveness and
optical radiation safety of the device by complying with either 1., 2., or 3. below:
1.  Certify Compliance with section 4.4 Optical radiation hazard with slit-lamp
microscopes (along with section 5.2 and Annex C) of the ISO  (International
Standards Organization) 10939.
 
2.  Demonstrate that the optical radiation emissions from the device do not exceed the
Threshold Limit Values (TLVs) for optical radiation established by the American
Conference of Governmental Industrial Hygienists (ACGIH) under worst case clinical
exposure conditions and times for all intended uses and applications.  This analysis
must include a comparison of the optical radiation emissions from the device to the
TLVs for Ultraviolet and infrared radiation, and visible and near infrared radiation
(i.e., blue light and aphakic hazards).  NOTE: Worst case clinical exposure conditions
and times refers to the exposure of a patient's eye to the maximum intensity of light
emitted from the device for the longest expected exposure times for each intended use
and application. Or,
3. Provide a side-by-side comparison using either a. or b. below:
a.  Compare the critical elements of the device (e.g., light source, lenses, filters, other
optical elements in the optical path) to those of a predicate or another legally
marketed device.  Include a side by side comparison of:
(1) beam geometry (solid angle subtended by the initial condensing lens at the
source, significant light losses in the optical path, and retinal area illuminated);
(2) the light source and its operating characteristics (electrical power and effective
color temperature); and
(3) the optical characteristics of all components including spectral transmittance
and the reflective/transmissive properties of any lenses, glass diffusion
windows or filters.  Also include the names and model identifications of the
manufacturers of the critical components.
b. Compare the optical radiation emissions associated with the device to those of a
predicate or another legally marketed device.  The comparison should include (1),
(2) and either (3) or (4) below: Page 4 - Slit Lamp Guidance
(1) the relative spectral radiant power distribution or any other relative spectral
radiometric distribution over the wavelength range from  400 nm to 700 nm;
(2) the maximum photometric luminance; and either
(3) the maximum radiometric quantities:
(i)  spectral irradiance or spectral radiance over the ultraviolet (UV)
wavelength range from 250 nm to 400 nm, and,
(ii)  irradiance for infrared (IR) wavelengths greater than 700 nm; or
(4) the optical radiation hazards as defined by ISO 15004 for: 
(i)  ultraviolet and infrared radiation, and
(ii) visible light and near IR radiation (blue-light weighted radiance and aphakic
weighted radiance).
D.  Electrical Safety:  Demonstrate electrical safety with bench testing, or declare
conformance to an electrical safety standard recognized by FDA (e.g., International
Electrotechnical Committee (IEC) 60601-1), or certify compliance with other electrical
safety standards (e.g., Underwriters Laboratory (UL) 544, UL 2601-1, etc.; testing data
may be required).  See Appendix II, Declaration of Conformity to a Recognized
Standard.
 
E.  Software  (if applicable):  Device should comply with Reviewer Guidance for Computer
Controlled Medical Devices Undergoing 510(k) Review (August 29, 1991) and ODE
Guidance for the Content of Premarket Submission Containing Software - Draft
Document, which will replace the 1991 guidance when finalized.   Or, you may declare
conformance with IEC 60601-1-4 (See Appendix II, Declaration of Conformity to a
Recognized Standard).
F. Sterilization:  Not required.
G. Disinfection:  Parts of the device that are designed to come into contact with the patient or
the operator should either be capable of easy disinfection or be protected by a single use,
disposable cover.
H. Labeling:  Include draft advertising, package labeling and users manual with instructions
for use.   Labeling should comply with the following:
1.  General labeling requirements:
 
a.   Labeling should include Device manufacturer name and address (21 CFR 801.1).
b.  Labeling should comply with all other applicable sections of 21 CFR 801 and
section 502 (Misbranded drugs and devices) of the Federal Food, Drug, and
Cosmetic Act. Page 5 - Slit Lamp Guidance
2.  Device specific labeling requirements:
 
a.   Labeling should include the Prescription device caution: ("Caution: Federal law
restricts this device to sale by or on the order of a Physician or Practitioner") (CFR
801.109(b)(1)).
 
b.  Labeling should include cleaning and disinfection procedures.
 
c.   Phototoxicity:  The following information should be provided to the user:
 
Because prolonged intense light exposure can damage the retina, the use of the
device for ocular examination should not be unnecessarily prolonged, and the
brightness setting should not exceed what is needed to provide clear visualization
of the target structures. This device should be used with filters that eliminate UV
radiation (< 400 nm) and, whenever possible, filters that eliminate
short-wavelength blue light (<420 nm).
 
      The retinal exposure dose for a photochemical hazard is a product of the radiance and
the exposure time.  If the value of radiance were reduced in half, twice the time
would be needed to reach the maximum exposure limit.
 
            While no acute optical radiation hazards have been identified for slit lamps, it is
recommended that the intensity of light directed into the patients eye be limited to
the minimum level which is necessary for diagnosis.  Infants, aphakes and persons
with diseased eyes will be at greater risk.  The risk may also be increased if the
person being examined has had any exposure with the same instrument or any
other ophthalmic instrument using a visible light source during the previous 24
hours.  This will apply particularly if the eye has been exposed to retinal
photography.
 
d. Lasers:  Products using lasers must comply with 21 CFR sections 1040.10 and
1040.11 and must be labeled according to 21 CFR 1040.10 (g).
  Page 6 - Slit Lamp Guidance
VI. References
IEC 60601- 1  - Medical electrical equipment - Part 1: General requirements for safety
IEC 60601- 1- 4  - Medical electrical equipment - Part 1: General requirements for safety - 4.
Collateral Standard: Programmable electrical medical systems.
ISO 10939  - Ophthalmic instruments - Slit-lamp microscopes
ISO 15004  - Ophthalmic instruments - General requirements and test methods
*In the United States, copies of these standards can be obtained from the American National Standards
Institute (ANSI), 11 West 42nd Street, New York, NY  10036.
UL 544  - Professional Medical and Dental Equipment
UL 2601-1  - Medical electrical equipment - Part 1: General requirements for safety
Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review
(August 29, 1991)
ODE Guidance for the Content of Premarket Submission Containing Software - Draft
Document (available at www.fda.gov/cdrh/ode/dtswguid.html)
1998 TLVs and BEIs: Threshold Limit Values for Chemical Substances and Physical Agents
and Biological Exposure Indices, American Conference of Governmental Industrial
Hygienists, (ACGIH, Cincinnati, OH), 1998.
ANSI/IESNA RP 27.1-96: Recommended Practice for Photobiological Safety for Lamps &
Lamp Systems - General Requirements.
ANSI/IESNA RP 27.3-96: Recommended Practice for Photobiological Safety for Lamps -
Risk Group Classification & Labeling. Page 7 - Slit Lamp Guidance
APPENDIX  I
Checklist for Slit Lamps
Information for the following items should be provided in a 510(k) submission:
General Requirements:
Submitters Name and Address
Contact Person, Telephone and Fax Number
Table of Contents with Pagination
Address of Manufacturing Facility/Facilities, and Sterilization Facility (if appropriate)
Device Trade or Proprietary Name
Device Common or Usual Name
Establishment Registration Number (if establishment registered)
Class
Classification Panel
Action taken to comply with Section 514 of the Act
Proposed labels, labeling, and Advertisements (if available) which describe the device, its
intended use, and directions for use
Truthful and Accurate Statement
510(k) Statement or Summary
Indications for Use Form
The Marketed Device(s) to which equivalence is claimed including labeling and description of
the device(s) and 510(k) number(s), if known.
Device Specific Requirements:
Materials (no flammable materials near light source)
Side-by-side comparison with predicate(s) (statement, table or chart of similarities and
differences with Marketed Device(s)
Optical equivalency and radiation safety certification or measurements
Electrical safety
Software certification
Disinfection information
Labeling: prescription device caution; disinfection procedures; phototoxicity information; laser
product labeling Page 8 - Slit Lamp Guidance
APPENDIX  II
Declaration of Conformity to a Recognized Standard
In preparing a declaration of conformity to recognized standards, manufacturers
should refer to the guidance document entitled, Guidance on the Recognition and
Use of Consensus Standards.  In accordance with this guidance, declarations of
conformity to recognized standards should include the following:
  An identification of the applicable recognized consensus standards that were
met;
  A specification, for each consensus standard, that all requirements were met,
except for inapplicable requirements or deviations noted below;
  An identification, for each consensus standard, of any way(s) in which the
standard may have been adapted for application to the device under review,
e.g., an identification of an alternative series of tests that were performed;
  An identification, for each consensus standard, of any requirements that were
not applicable to the device;
  A specification of any deviations from each applicable standard that were
applied (e.g., deviation from international standards which are necessary to
meet U.S. infrastructure conventions such as the National Electrical Code
(ANSI/NFPA 70));
  A specification of the differences that may exist, if any, between the tested
device and the device to be marketed and a justification of the test results in
these areas of difference; and,
  The name and address of any test laboratory or certification body involved in
determining the conformance of the device with the applicable consensus
standards and a reference to any accreditations of those organizations.