SCAR HEAL

K971468 · Specialty Systems, Inc. · MDA · Jun 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971468
• Device Name: SCAR HEAL
• Applicant: Specialty Systems, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Jun 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Hypertuophie Scars Keloid Scars

Device Story

Scar Esthetique/Rejuvaskin is a topical product intended for scar management. It is applied to hypertrophic and keloid scars to assist in their treatment. The device is intended for use by patients or clinicians in a home or clinical setting. It functions as a topical application to the affected skin area.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for the management of hypertrophic and keloid scars.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

100 1007

Mr. Glenn R. Joyner President Specialty Systems, Inc. - - - -1312 Veracruz Weston, Florida 33326

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Re: K971468

> Trade Name: Scar Esthetique/Rejuvaskin Regulatory Class: Unclassified Product Code: MDA Dated: April 20, 1997 Received: April 22, 1997

Dear Mr. Joyner:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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## Page 2 - Mr. Glenn R. Joyner

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. . . . . . . . . . . . .

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,

[signature]

Celia 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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K971468

510(k) Number (if known):

Device Name: REJUVASKIN

Indications For Use:

ત્વન્

Hypertuophie Scars
Keloid Scars

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971468 |
| | |

Presoription Use
(Por 21 CPR 801 105)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)