(119 days)
The StarLux™ Pulsed Light system is indicated for:
- The removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction.
- The treatment of benign pigmented lesions, including lentigines, nevi, melasma, and café-au-lait.
- The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
The StarLux™ is a versatile, light-based medical device consisting of a base unit and handpiece attachments.
The provided text describes a 510(k) submission for the Palomar StarLux™ Pulsed Light System. In a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, stating, "The differences in the specifications of the StarLux™ and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This means no new performance data or acceptance criteria were reported in this summary.
- Sample sized used for the test set and the data provenance: Not applicable, as a new study proving performance against acceptance criteria was not conducted for this 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a pulsed light system, not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary concludes that the StarLux™ System is "substantially equivalent" to the EsteLux™ Pulsed Light System and Lumenis VascuLight based on the fact that "differences in the specifications... do not result in different performance or raise new questions of safety or efficacy." This type of submission relies on the established safety and efficacy of the predicate devices.
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K 033549
Attachment 5
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Palomar StarLux™ Pulsed Light 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 01803781-993-2300 |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | November 10, 2003 |
| Device Trade Name: | Palomar StarLux™ |
| Common Name: | StarLux™ |
| Classification Name: | Laser surgical instrument for use in General andPlastic Surgery and in Dermatology(see: 21 CFR 878-4810).Product Code: GEXPanel: 79 |
| Legally-Marketed Predicate Device: | EsteLux™ Pulsed Light SystemLumenis VascuLight (Family of IPL) |
| System Description: | The StarLux™ is a versatile, light-based medicaldevice consisting of a base unit and handpieceattachments. |
| Intended Use of the Device: | The StarLux™ is a light-based medical devicedesigned for effective removal of unwanted hair,permanent hair reduction, and the treatment ofvascular and pigmented lesions. |
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| Performance Data: | The differences in the specifications of theStarLux™ and the predicate devices do not resultin different performance or raise new questions ofsafety or efficacy. |
|---|---|
| Conclusion: | Based on the foregoing, the StarLux™ System issubstantially equivalent to the legally-marketedclaimed predicate devices, i.e., the EsteLux™ andVascuLight. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2004
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Products, Inc. 131 Kelekent Lane Cary, North Carolina 27511
Re: K033549 Trade/Device Name: Palomar StarLux™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 30, 2004 Received: February 3, 2004
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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sct 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) 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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
(clia 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
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INDICATIONS FOR USE STATEMENT
510(K) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: StarLux™M
Indications for Use:
The StarLux™ Pulsed Light system is indicated for:
- The removal of unwanted hair from skin types I-VI, and to . effect stable long-term, or permanent, hair reduction.
- The treatment of benign pigmented lesions, including � lentigines, nevi, melasma, and café-au-lait.
- The treatment of vascular lesions, including port wine stains, . hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use ાર (per 21 CFR 801.109)
8
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K633549
§ 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.