(262 days)
No
The summary describes a pulsed light system with different handpieces and cooling technology, but makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is intended for the treatment of inflammatory acne and various benign pigmented lesions, indicating a therapeutic purpose.
No
The device is described as a treatment system for various dermatological conditions, not for diagnosing them. It is used to treat, not to identify or characterize disease.
No
The device description clearly states it is a "broad spectrum light-based medical device" and mentions "5 handpieces with Palomar's patented contact cooling technology," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of conditions like acne, pigmented lesions, warts, scars, and striae. These are all conditions treated directly on or within the body, not through the analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as a "broad spectrum light-based medical device" designed for "clinical applications." This points to a therapeutic device that applies energy to the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The StarLux system's function is to treat conditions directly, not to diagnose them through sample analysis.
N/A
Intended Use / Indications for Use
The StarLux™ System is intended for treatment of inflammatory acne and for the treatment of cutaneous lesions, including warts, scars and striae.
The StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.
Product codes
GEX
Device Description
The StarLux Pulsed Light System is a broad spectrum light-based medical device designed for a wide range of clinical applications. The StarLux offers 5 handpieces with Palomar's patented contact cooling technology, each specifically designed for the optimal treatment of specific clinical indications.
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)
Performance Data: The differences in the specifications of the StarLux™ and the predicates do not result in different performance or raise new questions of safety or efficacy. Conclusion: Based on the foregoing, the StarLux™ pulsed light system is substantially equivalent to the legally marketed claimed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Palomar EsteLux (K040081), Palomar StarLux (K033549), Palomar SpaLight (K003886)
Reference Device(s)
Lumenis IPL (K020839)
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
K041086/SCC1
JAN 1 3 2005
Attachment 4
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the StarLux™ 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: | April 22, 2004 |
| Device Trade Name: | Palomar StarLux™ Pulsed Light System |
| 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 Devices: |
Palomar EsteLux (K040081) Palomar StarLux (K033549) Palomar SpaLight (K003886) Lumenis IPL (K020839)
System Description:
The StarLux Pulsed Light System is a broad spectrum light-based medical device designed for a wide range of clinical applications. The StarLux offers 5 handpieces with Palomar's patented contact cooling technology, each specifically designed for the optimal treatment of specific clinical indications.
CONFIDENTIAL AND PROPRIETARY
1
K041086/SC01 p.28-
Intended Use of the Device: The StarLux™ System is intended for treatment of inflammatory acne and for the treatment of cutaneous lesions, including warts, scars and striae. Performance Data: The differences in the specifications of the StarLux™ and the predicates do not result in different performance or raise new questions of safety or efficacy. Conclusion: Based on the foregoing, the StarLux™ pulsed light system is substantially equivalent to the legally marketed claimed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511
Re: K041086 Trade/Device Name: StarLux™ Pulsed Light System 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: October 12, 2004 Received: October 21, 2004
Dear Ms. Moore:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications ferenced about and in sure) to legally marketed predicate devices marketed in interstate for use stated in the encreated)77, the enactment date of the Medical Device Amendments, or to commerce proc to they 20, 2017, 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). and Cosment Free (110.) that to novice, subject to the general controls provisions of the Act. The I ou may, develore, mains of the Act include requirements for annual registration, listing of general controls proficturing 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 If your device is classified (over a controls. Existing major regulations affecting your device can may be subject to back added of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou round in the Outs acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso oe aar nota a determination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I coolar statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or In the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty of events on (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and in your finding of substantial equivalence of your device to a legally promatics noticated 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
Indications for Use
K041086/SOO) 510(k) Number (if known):
Device Name: StarLux™ Pulsed Light System
Indications for Use:
The StarLux pulsed light system is intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number__Ko4/086