(121 days)
The Palomar LuxIR Handpiece is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Palomar LuxIR Handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Palomar LuxIR Handpiece delivers infrared light with a wavelength of 800-1800 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 describes the Palomar LuxIR Handpiece, an infrared handpiece intended for topical heating to temporarily relieve various types of pain and muscle issues. However, the document does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, nor does it provide performance data.
Instead, the document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device (Cutera Optional Infrared Handpiece K033768).
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth from the given text.
The "Performance Data" section explicitly states: "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." This indicates that a direct clinical performance study against specific acceptance criteria for the new device was not performed or deemed necessary for this 510(k) clearance, as its performance was inferred to be similar to the predicate device.
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K050370 1 of 2
Attachment 3
JUN 1 5 2005
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Palomar LuxIR handpiece is submitted in accordance with 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: | February 10, 2005 | |
| Device Trade Name: | Palomar LuxIR Handpiece | |
| Common Name: | Infrared Handpiece | |
| Classification Name: | Infrared Heating Lamp(21 CFR 890.5500). | |
| Legally-Marketed Predicate Device:K033768Cutera Optional Infrared Handpiece | ||
| System Description: | The Palomar LuxIR Handpiece delivers infraredlight with a wavelength of 800-1800 nm. Thecomplete system consists of a power source, chiller,a footswitch, and a handpiece connected to thepower unit with an umbilical. In standard use, thehandpiece is held in firm contact with the skin. Thehandpiece tip is water-cooled to provide active skincooling. System parameters and other systemfeatures are controlled from the user interface panelon top of the power unit. |
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K050370
| Intended Use of the Device: | |
|---|---|
| The Palomar LuxIR Handpiece is intended to emitenergy in the infrared spectrum to provide topicalheating for the purpose of elevating tissuetemperature for the temporary relief of minormuscle and joint pain and stiffness, the temporaryrelief of minor joint pain associated with arthritis,the temporary increase in local circulation whereapplied, and the relaxation of muscles. In addition,the Palomar LuxIR Handpiece may also helpmuscle spasms, minor sprains and strains, andminor muscular back pain. | |
| Performance Data: | The differences in the specifications of the PalomarLuxIR Handpiece and the predicate device do notresult in different performance or raise newquestions of safety or efficacy. |
| Conclusion: | Based on the foregoing, the Palomar LuxIRHandpiece is substantially equivalent to the legally-marketed claimed predicate device. |
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUN 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies Incorporated C/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511
Re: K050370
Trade/Device Name: Palomar LuxIR Handpiece Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 6, 2005 Received: May 9, 2005
Dear Ms. Moore:
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 10 wor would 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 – Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your were of your device of your device to a legally premarket nouffication. "The PDF Intering of basically 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 Patis and the pritised If you desire specific advice for your do need on our bland on the regulation entitled, and Conlict the Office of Comphalice as (21 t mart 807.97). You may obtain " Misbranding by relevence to premance nouthead.com the Act from the Division of Small
other general information on your responsibilities under the Act from the 2000 C20.00 other general information on your responsible and its toll-free number (800) 638-2041 or and Manufacturers, International and Consumer 11/vww.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. 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): K050370
1 of 1
10(k) Number (if known): K0502
Device Name:
Palomar LuxIR Handpiece
Indications for Use:
The Palomar LuxIR Handpiece is intended to provide topical heating for the The Palonial Luxir. Tranqpreco 16 incenture for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated and joint pain and striness, the cessportions where applied, and the whili artificis, the temporary mercuse the Palomar LuxIR Handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ivision Sign-C If) on Signeral, Restorative and Neurological Devices
510(k) Number K25370
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.