DIMISIL SCAR GEL

K023678 · Aesthetic and Reconstructive Technologies, Inc. · MDA · Jan 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023678
• Device Name: DIMISIL SCAR GEL
• Applicant: Aesthetic and Reconstructive Technologies, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Jan 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

Device Story

DIMISIL Scar Gel is a medical-grade silicone elastomer paste used for topical scar management. It is applied by the patient to keloid or hypertrophic scars resulting from trauma, surgery, or burns. The gel acts as a topical barrier to assist in scar management. It is supplied in 10ml aluminum tubes and is non-sterile. The device is intended for over-the-counter use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material, design, and functional similarity to legally marketed predicate devices.

Technological Characteristics

Medical-grade silicone elastomer; amorphous paste; non-sterile; supplied in 10ml aluminum tubes with puncture seal cap.

Indications for Use

Indicated for topical management of keloid or hypertrophic scars resulting from surgery, burns, abrasions, or lacerations. Contraindicated for use on open wounds.

Regulatory Classification

Identification

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

Predicate Devices

• Kelocote (Allied Biomedical Corporation)
• Kelocote Scar Gel (Hanson Medical, Inc.)

Submission Summary (Full Text)

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K023678

### AMENDMENT 7

#### 510(k) Summary

## JAN 2 3 2003

January 10, 2003

| Applicant: | Aesthetic and Reconstructive Technologies, Inc. (AART) |
|----------------------|--------------------------------------------------------|
| | 3545 Airway Drive, Suite 108 |
| | Reno, NV 89511 |
| | [phone] / FAX [phone] |
| Contact Person: | Catherine Riple |
| | Consultant for AART, Inc. |
| | [phone] |
| Proprietary Name: | DIMISIL Scar Gel |
| Common Name: | Medical Grade Silicone Elastomer |
| Classification Name: | Elastomer, Silicone, for Scar Management |

Substantial Equivalence: The DIMISIL Scar Gel is substantially equivalent in function, design, performance and materials to the Kelocote marketed by Allied Biomedical Corporation of Ventura, CA and the Kelocote Scar Gel marketed by Hanson Medical, Inc.of Kingston, WA.

Device Description: The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.

Intended Use: The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

Predicate Device: The DIMISIL Scar Gel is substantially equivalent in material, design, function, and performance to the Kelocote marketed by Allied Biomedical Corporation of Ventura. CA and the Kelocote Scar Gel marketed by Hanson Medical, Inc. of Kingston, WA. All products have identical intended uses and are offered in similar quantites.

Packaging: The DIMISIL Scar Gel is offered non-sterile. The scar gel will be packaged in a aluminum tube with a puncture seal cap top and crimped end. Each tube will be labeled and identified with lot number for traceability. The labeled tube will be packaged in a screen printed chipboard box along with a package insert for inventory and shipment.

Sterilization: The DIMISIL Scar Gel is offered non-sterile and not intended to be sterilized.

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JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesthetic and Reconstructive Technologies, Inc. c/o Catherine Riple 5871 Lone Pine Place Paso Robles, California 93446

Re: K023678

Trade/Device Name: DIMISIL Scar Gel Regulation Name: Silicone Elastomer for Scar Management Regulatory Class: Unclassified Product Code: MDA Dated: October 28, 2002 Received: November 1, 2003

Dear Ms. Riple:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Catherine Riple

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N. Milken

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

Enclosure

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### ATTACHMENT 1

Page 1 of 1

02367 510(k) Number (if known):_

DIMISIL SCAR GEL

Indications For Use:

Device Name:__________________________________________________________________________________________________________________________________________________________________

The intended use of the AART, Inc. "DIMISIL Scar Gel" is topical management of keloid or I he micaloon use of the Firer, morna of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| Division Sign-Off) |
|----------------------------------|
| Division of General, Restorative |
| and Neurological Devices |

| (k) Number | K023678 |
|------------|---------|
|------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Antinnal Formal 1-7-9