← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K070298 # MODIFICATION TO PALOMAR LUXIR HANDPIECE (K070298) _Palomar Medical Technologies, Inc. · GEX · Jul 3, 2007 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070298 ## Device Facts - **Applicant:** Palomar Medical Technologies, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jul 3, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The LuxIR is intended for photocoagulation of soft tissue in dermatologic applications. It also provides 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, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. ## Device Story LuxIR Handpiece is an accessory to the StarLux Pulsed Laser and Light System; emits infrared energy for photocoagulation and topical heating. System includes cart, console, chiller, footswitch, and handpiece. Operated by clinicians in dermatologic settings. Device elevates tissue temperature to provide therapeutic relief for musculoskeletal conditions and increase local circulation. Output is controlled infrared energy applied to the skin surface. Benefits include pain relief, muscle relaxation, and soft tissue coagulation. ## Clinical Evidence Bench testing only. ## Technological Characteristics Infrared wavelength energy emitter; accessory to StarLux Pulsed Laser and Light System; includes chiller and footswitch components. ## Regulatory 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. ## Predicate Devices - StarLux LuxIR Handpiece ([K060069](/device/K060069.md) & [K050370](/device/K050370.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) Summary LuxIR Handpiece K070298 This 510(k) summary is being submitted in accordance with 21 CFR 807.92 #### 1. SUBMITTER'S INFORMATION | NAME: | Palomar Medical Technologies, Inc. | JUL - 3 2007 | |----------|---------------------------------------------------------------------------------------------|--------------| | ADDRESS: | 82 Cambridge Street
Burlington, MA 01803
Phone: (781) 993-2300
Fax: (781) 993-2330 | | | CONTACT: | Sharon Timberlake, RAC, CCRA
Director of Regulatory Affairs | | DATE PREPARED: June 11, 2007 ### DEVICE INFORMATION 2. | TRADE/PROPRIETARY NAME: | Palomar LuxIR Handpiece | |-------------------------|--------------------------------------------------------------------------------------------------------| | COMMON/USUAL NAME: | Infrared Handpiece | | CLASSIFICATION NAME: | Laser surgical instrument
21 CFR §878.4810
Infrared therapeutic heating lamp
21 CFR §878.4810 | GEX, ILY ### 3. PREDICATE DEVICES Product Code: StarLux LuxIR Handpiece Palomar Medical Technologies, Inc. (K060069 & K050370) {1}------------------------------------------------ #### 4. INTENDED USE The LuxIR is intended for photocoagulation of soft tissue in dermatologic applications. It also provides 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, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. #### 5. DEVICE DESCRIPTION The LuxIR Handpiece is an accessory to the StarLux™ Pulsed Laser and Light System. The complete StarLux Pulsed Light System consists of a cart, system console, chiller, a footswitch, and a handpiece. The Palomar LuxIR Handpiece emits energy in the infrared wavelength. #### 6. PERFORMANCE DATA The review of the performance data provided in this notification demonstrates that the modified LuxIR Handpiece is substantially equivalent to its predicate device. #### 7. SUBSTANTIAL EQUIVALENCE The modified LuxIR Handpiece was found to be substantially equivalent to its predicate device because it shares identical indications for use, substantially similar technical characteristics, and operation. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The text is likely the name of a government agency. Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 3 2007 Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director, Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803 Re: K070298 Trade/Device Name: Palomar LuxIR Handpiece Regulation Number: 21 CFR 878.4810400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 11, 2007 Received: June 12, 2007 Dear Ms. Timberlake: 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 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. Sharon Timberlake, RAC, CCRA 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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html . Sincerely yours, Mark N. Melkerson Mark N. Melkerson 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): K070298 Device Name: Palomar LuxIR Handpiece Indications for Use: The LuxIR Handpiece is intended for: - Photocoagulation of soft tissue in dermatologic applications. . - . 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, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) (Division Sign-Off) OR Division of General, Restorative, and Neurological Devices Over-The-Counter Use 510(k) Number (Optional Format 1-2-96) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801.109) PALOMAR MEDICAL TECHNOLOGIES, INC. LUXIR HANDPIECE CONFIDENTIAL --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070298](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K070298) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com