(183 days)
The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels)
In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.
MedArt Corporation Uni-Laser™ 430
This document is a 510(k) clearance letter from the FDA for the MedArt Corporation Uni-Laser™ 430. It focuses on the regulatory approval of the device and its intended uses.
Unfortunately, this document does not contain the specific information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The provided text only states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use: hair removal in skin types I-IV, and soft tissue applications like coagulation of vascular lesions, and in contact mode for vaporization, ablation, incision, and excision of soft tissue.
To answer your questions, I would need a different type of document, such as:
- A clinical study report for the MedArt Corporation Uni-Laser™ 430.
- A detailed technical data submission to the FDA by MedArt Corporation.
- A performance testing report for the device.
Without such documentation, I cannot provide the requested information.
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MAY 1 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jan K. Enemaerke President MedArt Corporation 11772 Sorrento Valley Road, Suite 240 San Diego, California 92121
Re: K993815 Trade Name: MedArt Corporation Uni-Laser™ 430 Regulatory Class: II Product Code: GEX Dated: February 7, 2000 Received: February 11, 2000
Dear Mr. Enemaerke:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jan K. Enemaerke
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Durna R. Lochner.
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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SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MedArt Corporation Uni-Laser™ 430
Indications for Use Statement:
The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels)
In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use _ (Per 21 CFR 801.109)
OR
510(k) Number
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Duane R. Klines
(Division Sign-Off)
vision of General Restorative Devices
rev 2/2000
§ 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.