ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC

K083915 · Advanced Technology Laser Co., Ltd. · GEX · Jan 29, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083915
• Device Name: ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
• Applicant: Advanced Technology Laser Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow: - Intense Pulse Light Energy Wavelengths from 400 950 nm are indicated for the 1. treatment of inflammatory acne. - 2. Intense Pulse Light Energy Wavelengths from 560 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions includes port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melagenna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations. - Intense Pulse Light Energy Wavelengths from 700 1200 nm are indicated for the 3. treatment of unwanted hair (i.e., hair removal).

Device Story

Angelite Family of Intense Pulsed Light (IPL) Systems delivers pulsed-light energy via handpieces to target tissues. Device utilizes photothermolysis and photocoagulation principles to treat inflammatory acne, benign pigmented/vascular lesions, and unwanted hair. Wavelength ranges (400-950 nm, 560-1200 nm, 700-1200 nm) are selected based on clinical application. Operated by trained professionals in clinical/dermatology settings. Output energy affects target chromophores to achieve therapeutic outcomes; benefits include lesion clearance, hair reduction, and acne management.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Intense Pulsed Light (IPL) system; utilizes xenon flashlamp technology to deliver broad-spectrum light energy. Wavelength ranges: 400-950 nm, 560-1200 nm, 700-1200 nm. Includes interchangeable handpieces for specific clinical applications. System is a standalone unit for professional use.

Indications for Use

Indicated for patients requiring treatment of inflammatory acne, benign pigmented/vascular lesions (including warts, scars, striae, port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma of civatte, venous malformations), and hair removal.

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.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2009

Advanced Technology Laser, Co., Ltd. % Underwriters Laboratories, Inc. Mr. Morten Christensen 455 E. Trimble Road San Jose, California 95131-1230

Re: K083915

Trade/Device Name: Angelite Family of Intense Pulsed Light Systems 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: January 16, 2009 Received: January 23, 2009

Dear Mr. Christensen:

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

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Page 2 - Mr. Morten Christensen

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Sincerely vours.

Mark M Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - Indications for Use Statement

## Section II Indications for Use Statement

510(k) Number: Device Name: Indications for Use:

Angelite Family of Intense Pulsed Light Systems

The Angelite Family of Intense Pulsed Light Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow:

- Intense Pulse Light Energy Wavelengths from 400 950 nm are indicated for the 1. treatment of inflammatory acne.
- 2. Intense Pulse Light Energy Wavelengths from 560 1200 nm are indicated for the treatment of benign pigmented (epidermal and coetaneous) lesions including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions includes port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melagenna, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
- Intense Pulse Light Energy Wavelengths from 700 1200 nm are indicated for the 3. treatment of unwanted hair (i.e., hair removal).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (Please do not WRITE BELOW THE LINE-CONTINUE on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1 Division of General, Restorative, and Neurological De

**510(k) Number**