(121 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical components and intended use of an infrared light handpiece.
Yes
The device is intended to provide topical heating for the temporary relief of minor muscle and joint pain, stiffness, and other related conditions, which are therapeutic claims.
No
The device is intended for therapeutic purposes (pain relief, circulation increase, muscle relaxation) by elevating tissue temperature; it does not diagnose medical conditions.
No
The device description clearly outlines hardware components including a handpiece, power source, chiller, and footswitch, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic device that applies topical heating to the body for the relief of pain, stiffness, and muscle issues. This is a direct treatment applied to the patient's body.
- Device Description: The device delivers infrared light and is applied to the skin. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Palomar LuxIR Handpiece is intended to emit energy in the infrared spectrum 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.
Product codes
ILY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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:K033768 | ||
| Cutera Optional Infrared Handpiece | ||
| System Description: | 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. |
1
K050370
| Intended Use of the Device: | |
|---|---|
| The Palomar LuxIR Handpiece is intended to emit | |
| energy in the infrared spectrum 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. | |
| Performance Data: | 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. | |
| Conclusion: | Based on the foregoing, the Palomar LuxIR |
| Handpiece is substantially equivalent to the legally-marketed claimed predicate device. |
2
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.
3
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
4
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