(179 days)
Not Found
No
The summary describes a pulsed light therapy system with a microcontroller for controlling the light delivery. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is a "Pulsed Light Therapy System" indicated for the treatment of various medical conditions, including telangiectasia, rosacea, psoriasis, vitiligo, and vascular lesions.
No.
The "Intended Use / Indications for Use" section lists various treatment applications such as "treatment of facial, truncal or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos," indicating a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines hardware components including a control console unit, handpiece, and footswitch, indicating it is a physical medical device, not software-only.
Based on the provided information, the New Star Lasers UV-300 Pulsed Light Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The UV-300 is a light therapy system that delivers pulsed light directly to the patient's skin for therapeutic purposes (treating various skin conditions and for hair/tattoo removal). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes direct treatment of the patient's body, not analysis of biological specimens.
Therefore, the UV-300 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The New Star Lasers UV-300 Pulsed Light Therapy System is indicated for the treatment of facial, truncal or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos. The UV-300 may be used to treat patients with skin types I-VI.
Product codes
GEX
Device Description
The New Star UV-300 Pulsed Light Therapy System is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console unit, which houses the power supply, cooling system, cryogen source, and microcontroller, the handpiece, which contains the light source, and the footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed light
Anatomical Site
facial, truncal or leg
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)
Nonclinical Performance Data: None.
Clinical Performance Data: None.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020839, K020591, K020856, K020453, K013365, K022568
Reference Device(s)
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.
0
New Star Lasers, Inc.
1/2
UV-300 Pulsed Light Therapy System 510(k) Premarket Notification
510(k) SUMMARY
| Submitter: | New Star Lasers, Inc. |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Donald V. Johnson |
| Vice-President of Operations | |
| Telephone: | (916) 677-1912 |
| Facsimile: | (916) 677-1901 |
| Date Prepared: | December 20, 2002 |
| Device Trade Name: | UV-300 Pulsed Light Therapy System |
| Common Name: | Pulsed Light for Thermolysis/Photoepilation |
| Classification Name: | Instrument, Surgical, Powered, Laser. |
| 79-GEX, 21 C.F.R. § 878.4810 | |
| Legally Marketed Predicate | |
| Devices: | Lumenis, Inc. IPL Quantum, K020839 |
| Lumenis, Inc. Bclear, K020591 | |
| Radiancy, Inc. SpaTouch, K020856 | |
| Palomar, Inc. EsteLux, K020453 | |
| Alderm/MBC Prolite/Plasmalite, K013365, K022568 | |
| Description of the New Star UV-300 | |
| Pulsed Light Therapy System: | The New Star UV-300 Pulsed Light Therapy System is a |
| compact, self-contained system that delivers a beam of | |
| pulsed light at wavelengths of 300nm to 1400nm, which | |
| can be optimized at various wavelength ranges and | |
| delivered to the treatment site. The system consists of a | |
| control console unit, which houses the power supply, | |
| cooling system, cryogen source, and microcontroller, the | |
| handpiece, which contains the light source, and the | |
| footswitch. | |
| Intended use of the New Star UV- | |
| 300 Pulsed Light Therapy System: | The New Star Lasers UV-300 Pulsed Light Therapy |
| System is indicated for the treatment of psoriasis, | |
| vitiligo, atopic dermatitis (eczema), seborrheic | |
| dermatitis, vascular lesions, rosacea, hemangiomas, leg | |
| veins, hair removal, and tattoos. |
1
KC24259 2/2
| Nonclinical Performance Data: | None. |
|---|---|
| Clinical Performance Data: | None. |
| Conclusion: | The New Star Lasers UV-300 Pulsed Light Therapy System is substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of psoriasis, vitiligo, atopic dermatitis (eczema) seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, and tattoos. |
| Additional Information: | None requested at this time |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing the wings and two lines representing the body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2003
Mr. Donald V. Johnson Vice President of Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K024259
Trade/Device Name: UV-300 Pulsed Light Therapy 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: March 21, 2003 Received: March 24, 2003
Dear Mr. Johnson:
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.
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Page 2 - Mr. Donald V. Johnson
This letter will allow you to begin marketing vour 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 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
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
510(k) Number: __K02 42 S9
Device Name: New Star Lasers UV-300 Pulsed Light Therapy System
Indications for Use:
The New Star Lasers UV-300 Pulsed Light Therapy System is indicated for the treatment of facial, truncal or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos. The UV-300 may be used to treat patients with skin types I-VI.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use
Muriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024259