Guidance for Industry
Guidance for Dermabrasion Devices
Document issued on:  March 2, 1999
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Plastic and Reconstructive Surgery Devices Branch
Division of General and Restorative Devices
Office of Device Evaluation Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to,
Stephen P. Rhodes, HFZ-410, 9200 Corporate Boulevard, Rockville, Maryland 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
Anthony D. Watson at (301) 594-3090 or by electronic mail at ADW@cdrh.fda.gov.
Additional Copies
World Wide Web home page:  http://www.fda.gov/cdrh/index.html or CDRH Facts on
Demand at 1-800-899-0381 or 301-827-0111, specify number 2248 when prompted for
the document shelf number. 1
Guidance  for Dermabrasion Devices
Purpose
The purpose of this guidance document is to assist those persons interested in submitting a
premarket notification to FDA for devices intended to abrade or erode skin.
Regulatory Classification
Dermabrasion devices are preamendment devices with indications for general dermabrasion, scar
revision, acne scar revision, and tattoo removal.  There are two general types of dermabrasion
devices:  manual and motorized.
Manual dermabrasion devices are classified in 21 CFR 878.4800 as Class I devices and were
exempted from premarket notification procedures in 1994.
Motorized dermabrasion devices are classified in 21 CFR 878.4820 as Class I devices and were
exempted from premarket notification procedures by the Food and Drug Administration
Modernization Act in February of 1998.
As described in 21 CFR 878.9, exemption of class I devices does not apply where:  1) the device
is intended for a different use, e.g., a different medical purpose; or 2) the device operates using a
different fundamental scientific technology.  Therefore, as long as a sponsor intends to market a
dermabrasion device that is similar to those that are already legally on the market, a premarket
notification (510(k)) is not necessary.  However, a 510(k) would be required if a sponsor intends
to market a dermabrasion device that has different indications than those stated above, contains
output parameters (pressure, rotations per minute) which are intended for indications different
from those of legally-marketed devices, operates via a different mode of action, or uses a different
abrasion substrate.
Content
A 510(k) for a dermabrasion device should contain:
  Indications for use form
  510(k) summary or a 510(k) statement
  Truthful and accuracy statement
  Device description, including a schematic or engineering drawing
  Sterilization information
  Predicate device labeling
  Proposed device labeling
1This document is intended to provide guidance.  It represents the Agencys current thinking on this topic.
It does not create nor 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
statute, regulations, or both.
page 1 Data comparing the safety and effectiveness of the device to a legally marketed dermabrasion
device should be provided for indications for dermabrasion devices other than general
dermabrasion, scar revision, and tattoo removal.  FDA considers this device to be a non-
significant risk device based on the fact that it does not meet any of the criteria delineated in 21
CFR  812.3(m).  It is suggested that sponsors of clinical trials for non-significant risk devices
provide the agency with a copy of the study protocol prior to commencing the study to ensure
that the protocol will provide adequate data to make a decision on the devices substantial
equivalence to a legally marketed device.
In the device description, please include material composition, mode of action and output
parameters.  Also within this section, a comparison between the proposed device and the
predicate device should be presented.
The sterilization section of the 510(k) should specify the device components that are pre-sterilized
or require sterilization prior to use.  The mode of sterilization, the sterility assurance level (SAL)
of the process and method of validation should be specified as well.  The labeling should contain
instructions for a validated method of sterilizing any device provided non-sterile or any reusable
components.
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