(59 days)
Not Found
No
The summary describes a laser system with standard controls and no mention of AI/ML terms, image processing, or data sets for training/testing.
Yes
The device is indicated for skin resurfacing, which is a therapeutic treatment.
No
The device description and intended use indicate it is a therapeutic laser system for skin resurfacing, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a power supply unit, cooling unit, foot switch, and hand piece, indicating it is a physical laser system, 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 is "skin resurfacing." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The description details a laser system used to deliver light pulses to the skin. This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are specifically designed for testing samples in vitro (outside the body) to diagnose or monitor medical conditions.
Therefore, the Palomar Q-YAGTM Nd:YAG laser system, as described, is a therapeutic or cosmetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Palomar Q-YAGTM Nd:YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The complete system consists of a power supply unit, a cooling unit, a foot switch, and the hand piece that connects the laser unit and cooling unit using an umbilical cord. In standard use, the hand piece is held against the treatment area and the light pulse is delivered when the foot switch and hand switch is depressed. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
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 differences in the specifications of the laser and the predicate device do not result in different performance or raise new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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023967
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JAN 2 7 2003
Attachment 4
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Q-YAGTM Nd:YAG Laser System 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: | 11/25/02 |
| Device Trade Name: | Palomar Q-YAGTM Nd:YAG Laser System |
| Common Name: | Q:Switched Nd:YAG |
| Classification Name: | Laser surgical instrument for use in General and |
| Plastic Surgery and in Dermatology | |
| (see: 21 CFR 878-4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Device: | ThermoLase SoftLight |
| K971207 | |
| System Description: | The complete system consists of a power supply |
| unit, a cooling unit, a foot switch, and the hand | |
| piece that connects the laser unit and cooling unit | |
| using an umbilical cord. In standard use, the hand | |
| piece is held against the treatment area and the light | |
| pulse is delivered when the foot switch and hand | |
| switch is depressed. Laser parameters and other | |
| system features are controlled from a display panel |
located on the front of the power supply unit.
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023967 2/2
Intended Use of the Device:
The Palomar Q-YAG™ is indicated for laser skin resurfacing with or without adjuvant preparation.
The differences in the specifications of the
laser and the predicate device do not result in
Performance Data:
Conclusion:
different performance or raise new questions of safety or efficacy. Based on the foregoing, the Palomar Q-YAGTM
Nd:YAG Laser System is substantially equivalent to the legally-marketed claimed predicate device, i.e., the Thermolase SoftLight.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in black, contrasting with the white background.
JAN 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511
Re: K023967
Trade/Device Name: Palomar Q-YAGTM Nd:YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 27, 2002 Received: November 29, 2002
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 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
3
Page 2 -- Ms. Marcy Moore
(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. 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 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
KO23967 510(K) Number:
Device Name: Palomar Q-Y AGTM Nd: Y AG Laser System
Indications for Use:
The Palomar Q-YAGTM Nd:YAG laser system is indicated at the 1064 nm wavelength for skin resurfacing with or without adjuvant preparation.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR Over-the-Counter Use --(per 21 CFR 801.109)
Miriam C. Provost
Ivision Sign-Off) Division of General, Restorative and Neurological Vevices
Number K023967