(153 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
Yes
The device is intended for various therapeutic purposes, including photocoagulation of soft tissue, relief of minor muscle and joint pain, and relaxation of muscles.
No
The device is intended for therapeutic purposes (photocoagulation and heating for pain relief, circulation, and muscle relaxation), not for diagnosing a condition.
No
The device description explicitly states it is a "Handpiece" and an "accessory" to a "Pulsed Laser and Light System," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for photocoagulation of soft tissue and topical heating for pain relief and increased circulation. These are therapeutic applications performed directly on the patient's body.
- Device Description: The device is a handpiece that emits infrared energy, used as part of a laser and light system. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is clearly used in vivo (on the living body) for therapeutic purposes.
N/A
Intended Use / Indications for 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.
Product codes
GEX, ILY
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The review of the performance data provided in this notification demonstrates that the modified LuxIR Handpiece is substantially equivalent to its predicate device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary LuxIR Handpiece
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
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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