KELOCOTE SCAR GEL AND KELOCOTE LASER GEL

K973572 · Hanson Medical, Inc. · MDA · Oct 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973572
• Device Name: KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
• Applicant: Hanson Medical, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Oct 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

KELOCOTE SCAR GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ASSOCIATED ERYTHEMA SECONDARY TO ANY TRAUMA CAUSING SCARS KELOCOTE LASER GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ERYTHEMA SECONDARY TO LASER RESURFACING

Device Story

Topical silicone elastomer gel; applied as thin coat to skin; forms invisible thin sheet; manages hypertrophic/keloid scars and erythema; used post-trauma or post-laser resurfacing; patient-applied; amorphous paste consistency; contains silicone rubber; optional titanium oxide or zinc oxide additives for color/consistency.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition and intended use.

Technological Characteristics

Amorphous silicone elastomer paste; manufactured from Applied Silicone LSR-30 and/or Nusil Technology MED 4210/4211 Silicone Rubber (MAF 612); optional additives include Titanium Oxide or Zinc Oxide; packaged in aluminum tubes.

Indications for Use

Indicated for management of hypertrophic scars, keloid scars, and associated erythema secondary to trauma or laser resurfacing.

Regulatory Classification

Identification

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

Predicate Devices

• Kelocote Gel (Allied Biomedical)
• PMT's Gel Sheeting

Submission Summary (Full Text)

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## OCT 2 1 1997

K973572

## TAB G

## 510 (k) Summary

Substantial Equivalence:

Kelocote Scar Gel and Kelocote Laser Gel are topical silicone elastomer products that are substantially equivalent to Kelocote Gel of Allied Biomedical. Allied Biomedical's kelocote was found SE to PMT's Gel Sheeting.

Intended Use:

The intended use of Kelocote Scar and Kelocote Laser Gels are for . the management of hypertrophic scars and associated erythema which is commonly associated with scars in the first few months post trauma. Kelocote Scar Gel is applied in a very thin coat and the excess is wiped away. This forms a thin sheet on the skin which is very nearly invisible.

Physical and Chemical Properties:

Kelocote Gel is described as an amorphous paste with minimal to no elasticity or strength. Kelocote Gel in one form will contain Titanium Oxid or Zinc Oxide for color and concistency. Kelocote is manufactured from Applied Silicone's LSR-30 and or Nusil Technology's MED 4210 and 4211 Silicone Rubber MAF 612.

Package Description:

Packaging will consist of aluminum tubes of varying volumes from 1/6 ounce to 2 ounces. Tubes will be blind mouth with crimped ends. Tubes will be shipped individually or in boxes of 12 in corrugated protective outer boxes.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Kathy Hanson Richardson .Regulatory Affairs Hanson Medical Inc. 19325 58th Place N.E. Seattle, Washington 98155

OCT 2 1 1997

Re: K973572

> Trade Name: Kelocote Scar Gel and Kelocote Laser Gel Regulatory Class: Unclassified Product Code: MDA Dated: September 10,1997 Received: September 19, 1997

Dear Ms. Richardson:

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 - Ms. Kathy Hanson Richardson

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,

Celia M. Witten, Ph.D., M.D.

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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510(k) Number (if known): K973572

Device Name: KELOCOTE SCAR_GEL, KELOCOTE LASER GEL

Indications For Use:

KELOCOTE SCAR GEL:

FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ASSOCIATED ERYTHEMA SECONDARY TO ANY TRAUMA CAUSING SCARS

KELOCOTE LASER GEL:

FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ERYTHEMA SECONDARY TO LASER RESURFACING

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices

| 510(k) Number | L973572 |
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Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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