AIP INTENSE PULSED LIGHT SYSTEM

K041554 · Aesthera Corporation · GEX · Apr 27, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041554
• Device Name: AIP INTENSE PULSED LIGHT SYSTEM
• Applicant: Aesthera Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction. The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Device Story

Portable tabletop intense pulsed light (IPL) system; 400-1200 nm spectrum; utilizes Photo-Pneumatic technology. Device consists of main console connected via umbilical to handpiece. Handpiece features replaceable intelligent tip for light transmission; tip maintains seal with patient skin during emission to contain light. Operated by clinician in clinical setting. User controls and interface integrated into handpiece for ergonomics. Light energy targets vascular/pigmented lesions or hair follicles; clinical output facilitates lesion clearance or hair reduction. Benefit includes non-invasive treatment of dermatological conditions across all skin types.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Intense pulsed light delivery system (400-1200 nm); Photo-Pneumatic technology; portable tabletop console with umbilical-connected handpiece; replaceable intelligent tips; ergonomic handpiece-integrated controls.

Indications for Use

Indicated for treatment of benign vascular and pigmented lesions and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI).

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

• SkinStation (K032205)
• SPR (K033181)
• ClearTouch (K030897)
• SpaTouch Pro (XtremeClear) (K020856)
• SpaTouch (K992482)
• StarLux (K033549)
• MediLux (K020941)
• EsteLux (K020453)
• Palomar Medical Technologies, Inc. (K010618)
• Palomar Medical Technologies, Inc. (K003886)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

# K041554

This 510(k) Summary of Safety and Effectiveness for the AesThera AIP ™ Intense Pulsed Light System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

| Applicant: | AesThera Corporation<br>6111 Southfront Road<br>Suite E<br>Livermore, CA 94550<br><br>Bob Anderson<br>Chief Financial Officer |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | C. Robert Payne, Jr., P.E.<br>Regulatory Affairs Consultant<br>CRP Enterprises<br>P.O. Box 2608<br>Morgan Hill, CA 95038<br>Telephone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Preparation Date: | 6 June 2004 |
| Device Trade Name: | AIPTM Intense Pulsed Light System |
| Common Name: | Pulsed Flash Lamp |
| Classification Name: | Surgical instrument for use in general and<br>plastic surgery and in dermatology<br>(21 CFR 878-4810) |
| Product Code: | GEX |
| Predicate Devices: | |

- SkinStation™, SPR™, ClearTouch™ , SpaTouch Pro (XtremeClear ™), . SpaTouch ™ (Radiancy (Israel) Ltd.) (K032205, K033181, K030897, K020856, K992482)
- StarLux™, MediLux™, EsteLux™ (Palomar Medical Technologies, Inc.) . (K033549, K020941, K020453, K010618, K003886)

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#### Device Description:

The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.

#### Intended Use of the Device:

The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.

The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

#### Substantial Equivalence to Predicate Devices:

The AIP Intense Pulsed Light System, which is intended for the following; the treatment of benign vascular and pigmented lesions, and permanent hair reduction, is substantially equivalent in design and materials to the listed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle, with three stylized lines representing the bird's wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2005

AesThera Corporation C/o C. Robert Payne, Jr., P.E. RA/ QA Consultant CRP Enterprises P.O. Box 2608 Morgan Hill, California 95038

Re: K041554 Trade/Device Name: AIP™ Intense Pulsed Light System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 16, 2005 Received: March 21, 2005

Dear Mr. Payne:

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, 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 (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 - Mr. C. Robert Payne, Jr., P.E.

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). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

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Sincerely yours,

Ron G. Th

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

| 510(k) Number: | New submission<br>NAME OF LOT LIES LOOM | 1 00 | Caroline, and and and the production of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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AIP TM Intense Pulsed Light System Device Name:

Indications for Use:

The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction.

The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).

Prescription Use _X_

OR (per 21 CFR 878-4810)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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