CHROMOSCAN SCANNING SYSTEM

K980753 · Mehl/Biophile Intl., Inc. · GEX · Jun 29, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980753
• Device Name: CHROMOSCAN SCANNING SYSTEM
• Applicant: Mehl/Biophile Intl., Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used with the MEHL Chromos 694 Ruby Laser for the removal of unwanted body and facial hair.

Device Story

ChromoScan is a handheld scanner attachment for the Chromos 694 Ruby Laser. It automates the delivery of laser energy by creating a mathematically precise treatment grid, replacing manual one-hair-at-a-time procedures. The device optimizes thermal recovery time and reduces overlap, increasing efficiency and safety. It is operated by a clinician. The scanner does not exceed the fluence of the parent laser (max 20J/cm²). Safeguards within the parent laser's software ensure fluence limits are maintained. The output is a grid-based laser delivery, which reduces operator error and tedium, potentially improving patient outcomes through more consistent treatment.

Clinical Evidence

Preliminary use on subjects in Europe produced no safety concerns. No formal clinical trial data provided; substantial equivalence is supported by bench testing and thermographic profile comparisons.

Technological Characteristics

Handheld scanner attachment for 694nm Ruby Laser. Produces 7mm spot size. Maximum fluence 20J/cm². Integrates with parent laser software for safety monitoring. Bench testing via computer-generated thermographic profiles.

Indications for Use

Indicated for the removal of unwanted body and facial hair in patients requiring laser hair removal treatment.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• fiber optic handpiece (parent laser delivery attachment)

Submission Summary (Full Text)

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JUN 29 1998

MEHL / Biophile International CORPORATION

K980753

4127 N.W. 27th Lane, Suite A Gainesville, Florida 32606 Phone [phone] Fax [phone]

## 510(k) SUMMARY

## CHROMOSCAN SCANNER

for the

## CHROMOS 694 RUBY LASER FOR HAIR REMOVAL

The ChromoScan is a scanner which is used with the Chromos 694 Ruby Laser for the removal of unwanted body and facial hair. Lasers for such dermatological use were reviewed by the General and Plastic Device Classification Panel and are assigned the Product Code 79 GEX. They are regulated under 21 CFR 878.4810 as Class II devices.

The hand held ChromoScan attachment enables treatment of multiple, rather than single hairs, thereby increasing efficiency and adding to the safety of the parent laser. The unit lays down a mathematically precise treatment grid whereby overlap is reduced and thermal recovery time is optimized. It is expected to lessen potential operator error by diminishing the time and tedium associated with one-hair-at-a-time hair removal procedures. Moreover, safeguards within the Chromos 694's intrinsic software insure that the scanner's fluences do not exceed those of the basic laser, i.e., no more than 20J/cm .

ChromoScan is substantially equivalent to the other laser delivery attachment, the fiber optic handpiece. Both produce the same spot size, 7mm, and energies, as shown by computergenerated thermographic profiles. Reliability of the scanner is assured by state-of-the-art validation procedures and final system inspections.

Preliminary use of the ChromoScan on subjects in Europe produced no concerns about safety.

Ron Bohn

Thomas Blake, R.Ph Regulatory Strategist

5/13/98

Date

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 29 1000

Thomas Blake, R.Ph. ·MEHL/Biophile International Corporation 48 Mt. Olive Road Budd Lake. New Jersey 07828

Re: K980753 Trade Name: Chromoscan Scanner Regulatory Class: II Product Code: GEX Dated: May 27, 1998 Received: May 28, 1998

Dear Mr. Blake:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Thomas Blake

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page ______ 1___ of __________________________________________________________________________________________________________________________________________________________

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510(k) Number (if known):_ K980753____________________________________________________________________________________________________________________________________________

Device Name: CHROMO SCAN SCANNER____

Indications for Use:

To be used with the MEHL Chromos 694 Ruby Laser for the removal of unwanted body and facial hair.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | K980753 |
| 510(k) Number | |

| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|---|----|-----------------------------------------------|
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