(30 days)
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 treatment of inflammatory acne.
- 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 treatment of unwanted hair (i.e., hair removal).
Angelite Family of Intense Pulsed Light Systems
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "Angelite Family of Intense Pulsed Light Systems," indicating its substantial equivalence to a legally marketed predicate device.
The document includes:
- The device name and regulatory information.
- Indications for Use.
- Basic FDA contact and regulatory compliance information.
It does not contain:
- Specific acceptance criteria for the device's performance.
- Details of any study (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) that would demonstrate the device meets acceptance criteria.
The information provided confirms that the device is cleared for market based on substantial equivalence, but it does not elaborate on the specific performance metrics or studies used to establish that equivalence beyond listing the indications for use.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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.
-
- 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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.