(119 days)
Not Found
No
The summary describes a light-based medical device for various dermatological treatments and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is indicated for medical treatments such as the removal of unwanted hair, and the treatment of benign pigmented lesions and vascular lesions, which are therapeutic applications.
No
Explanation: The device is indicated for treatment of various conditions (hair removal, pigmented lesions, vascular lesions) and does not perform diagnosis.
No
The device description explicitly states it consists of a "base unit and handpiece attachments," indicating it is a hardware-based system, not software-only.
Based on the provided information, the StarLux™ Pulsed Light system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (hair removal, treatment of pigmented lesions, treatment of vascular lesions) are all procedures performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The description of a "light-based medical device consisting of a base unit and handpiece attachments" aligns with a device used for external treatments, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the StarLux™ Pulsed Light system is a therapeutic or aesthetic medical device used for external treatments, not an in vitro diagnostic device.
N/A
Intended Use / 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 cafe-au-lait.
- The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
Product codes
GEX
Device Description
The StarLux™ is a versatile, light-based medical device consisting of a base unit and handpiece attachments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
EsteLux™ Pulsed Light System, Lumenis VascuLight (Family of IPL)
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
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 01803 | |
| 781-993-2300 | |
| 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 and |
| Plastic Surgery and in Dermatology | |
| (see: 21 CFR 878-4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Device: | EsteLux™ Pulsed Light System |
| Lumenis VascuLight (Family of IPL) | |
| System Description: | The StarLux™ is a versatile, light-based medical |
| device consisting of a base unit and handpiece | |
| attachments. | |
| Intended Use of the Device: | The StarLux™ is a light-based medical device |
| designed for effective removal of unwanted hair, | |
| permanent hair reduction, and the treatment of | |
| vascular and pigmented lesions. |
1
| Performance Data: | 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. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Based on the foregoing, the StarLux™ System is
substantially equivalent to the legally-marketed
claimed predicate devices, i.e., the EsteLux™ and
VascuLight. |
2
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)
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Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K633549