(88 days)
The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.
Not Found
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria, device performance studies, or details about the training and test sets and their ground truth establishment.
The document is an FDA 510(k) clearance letter for the "Laser 21" device, indicating that it has been deemed "substantially equivalent" to legally marketed predicate devices for the removal of unwanted hair in Fitzpatrick skin types I-IV.
The letter focuses on regulatory approval and compliance, and does not contain the specifics of any performance studies or validation data that would typically be found in a study report. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or other study details.
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Image /page/0/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol is a stylized representation of an eagle or bird with three curved lines forming its wings and body. The seal is black and white and appears to be of official nature.
DEC 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ya-Man Ltd c/o Mr. Robert T. Handren, Jr., M.S. Handren Associates, Inc. 5818 Princess Caroline Place Leesburg, Florida 34748
Rc: K032944 Trade/Devicc Name: Laser 21 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: September 17, 2003 Received: September 29, 2003
Dear Mr. Handren:
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 gencral 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. I'DA may publish further announcements concerning your device in the Federal Register.
Please he advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a dotermination 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 sct 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. Robert T. Handren, Jr., M.S.
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), plcase contact the Office of Compliance at (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours.
sincerely yours,
Mark N Melkusso
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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510(k) Number (if known):
:
Device Name: Laser 21
Indications For Use:
The Ya-Man, Ltd. Laser 21 diode laser system is indicated for the removal of unwanted hair in Fitzpatrick skin types I-IV.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use | ✓ |
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| Over-The-Counter Use | _________________ |
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| ---------------------- | ------------------- |
(Optional Format 1-2-96)
for Mark N. Milliken
Vision Technology Representative
Audiological Devices
§ 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.