(66 days)
The IRIDEX® Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.
The Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light.
The provided text is a 510(k) Summary and an FDA clearance letter for the IRIDEX Apex 800 Dermatology Laser System. It does not contain information on acceptance criteria for a study demonstrating device performance, nor details of such a study.
Therefore, I cannot provide the requested table and study information based on the given input. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, not on proving specific performance criteria through a clinical study with detailed statistical results.
The document indicates that the Apex 800 is substantially equivalent to legally marketed predicate devices, which means its safety and effectiveness are considered to be similar to those already on the market. This type of submission generally relies on comparing the new device's technological characteristics and intended use to existing devices, rather than conducting new, extensive clinical trials to establish new performance metrics.
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20949
510(k) Summary IRIDEX® Corporation Apex® 800 Dermatology Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
John D'Angelo Contact Person: (650) 962-8848 ext. 3905
Date Prepared: March 11, 2002
Device Information
| Trade Name: | Apex 800 Dermatology Laser System |
|---|---|
| Classification Name: | Laser Instrument, Surgical, Powered |
| CFR Section: | 878.4810. |
| Product Code: | GEX. |
Equivalent Devices
The Apex 800 Laser System is substantially equivalent in intended use and technological characteristics to other currently legally marketed dermatology laser devices including the IRIDERM Apex 800 (K992298), the Coherent LightSheer (K003614), the Cynosure Apogee - TKS and Photogenica DL Laser Systems (K992757 and K010005) and the Palomar SLP 1000 (K013028).
Device Description
The Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light.
Intended Use
The IRIDEX Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.
Conclusion
The Apex 800 is substantially equivalent to the identified predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 2002
Mr. John D'Angelo Vice President, Regulatory Affairs and Quality Assurance IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Re: K020849
Trade/Device Name: Apex 800 Dermatology Laser System Regulation Number: 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 11, 2002 Received: March 15, 2002
Dear Mr. D'Angelo:
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. John D'Angelo
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Pending K020849
Device Name: Apex® 800 Dermatology Laser System
Indications For Use:
The IRIDEX® Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020849
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use _
§ 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.