(52 days)
The LuxIR is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
The Palomar LuxIR Handpiece delivers infrared light with a wavelength of 850-1350 & 1700-2500 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to provide active skin cooling. System parameters and other system features are controlled from the user interface panel on top of the power unit.
The provided text does NOT include details about acceptance criteria or a study proving device performance in the way requested. It is a 510(k) summary for a medical device (Palomar LuxIR Handpiece) seeking clearance based on substantial equivalence to predicate devices. This type of submission typically focuses on comparing the new device's specifications and intended use to existing, legally marketed devices, rather than presenting a performance study against specific acceptance criteria.
Therefore, for aspects like:
- Table of acceptance criteria and reported device performance
- Sample sizes for test or training sets
- Data provenance
- Number and qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone performance
- Type of ground truth used
- How ground truth for training was established
The document contains no information.
The document states:
- Intended Use: The Palomar LuxIR Handpiece is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
- Performance Data: The summary mentions "Performance Data" as a header but provides no actual data, only a conclusion.
- Conclusion: "The differences in the specifications of the Palomar LuxIR Handpiece and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the Palomar LuxIR Handpiece is substantially equivalent to the legallymarketed claimed predicate device."
This indicates that the clearance was based on demonstrating equivalence, not on a new clinical performance study establishing specific acceptance criteria for efficacy or safety.
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Attachment 3
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Palomar LuxIR handpiece is Fills 510(1) Bannial - owith the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Palomar Medical Technologies, Inc. |
|---|---|
| Address: | 82 Cambridge St.Burlington, MA 01803 |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | January 6, 2006 |
| Device Trade Name: | Palomar LuxIR Fractional Handpiece |
| Common Name: | LuxIR Photocoagulator |
| Classification Panel: | General and Plastic Surgery (878.4810) |
| Legally-Marketed Predicate Device: | K990850; K974168; K911648Coopersurgical/Redfield Infrared Coagulator |
| System Description: | The Palomar LuxIR Handpiece delivers infraredlight with a wavelength of 850-1350 & 1700-2500nm. The complete system consists of a powersource, chiller, a footswitch, and a handpiececonnected to the power unit with an umbilical. Instandard use, the handpiece is held in firm contactwith the skin. The handpiece tip is water-cooled toprovide active skin cooling. System parameters andother system features are controlled from the userinterface panel on top of the power unit. |
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Intended Use of the Device:
:
The Palomar LuxIR Handpiece is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
Performance Data:
Conclusion:
The differences in the specifications of the Palomar LuxIR Handpiece and the predicate device do not result in different performance or raise new questions of safety or efficacy.
Based on the foregoing, the Palomar LuxIR Handpiece is substantially equivalent to the legallymarketed claimed predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three parallel lines forming the body and wings, and three curved lines representing the legs and feet.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 MAR 2
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511
Re: K060069
Trade/Device Name: Palomar LuxIR Fractional Handpiece 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 20, 2006 Received: January 23, 2006
Dear Ms. Moore:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for use stated in the encreated of 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 r va may), and every isions 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 or any I vatural 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 Cr re rate 677, accesses (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Moore
This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle witi anow you to begin maneting of substantial equivalence of your device to a legally premarket nonneation: "The PDF 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 If you desire specific aurrice for your (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Snall other general mionnal 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/industry/support/index.html
Sincerely yours,
ell
Mark N. Malkerson, M.S.
Mark N. Melkerson, M.S. Acting 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
510(k) Number (if known):
Palomar LuxIR Fractional Handpiece Device Name:
Indications for Use:
The LuxIR is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
Over-The-Counter Use X Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K060069 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.