(58 days)
Not Found
Not Found
No
The device description focuses on the hardware components and laser parameters, with no mention of AI or ML capabilities for image analysis, treatment planning, or other functions.
Yes
The device is intended for "treatment of leg veins," which directly indicates a therapeutic purpose.
No
The provided text clearly states the device is "intended for the treatment of leg veins" and describes it as a laser system that "delivers pulsed infrared laser light". It also mentions "clinical studies were conducted to provide assurance that differences in the specifications... do not result in different performance or raise new questions of safety or efficacy" and that it is a "safe and effective tool for the treatment of leg veins". There is no mention of the device being used for diagnosis, disease detection, or measurement of physiological parameters.
No
The device description clearly outlines hardware components such as a console, footswitch, handpiece, and a laser array, indicating it is a physical medical device, not software-only.
Based on the provided information, the StarLight™ Pulsed Diode Array Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of leg veins in Dermatology and Plastic Surgery procedures." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The description details a laser system that delivers light pulses to the skin for treatment. This is a physical intervention, not a diagnostic test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The StarLight system is a therapeutic device used for treatment.
N/A
Intended Use / Indications for Use
The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.
Product codes
GEX
Device Description
The StarLight system delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The corresponding pulse energy delivered through the 9 x 9 mm handpiece tip is 8 – 32 J. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dermatology and Plastic Surgery procedures.
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)
Clinical studies were conducted to provide assurance that differences in the specifications of the StarLight system and the predicate device do not result in different performance or raise new questions of safety or efficacy. Observations of vessel clearing and skin responses were recorded as a function of vessel and treatment parameters. Vessel effects included reduction in vessel diameter, vessel coagulation, and vessel disappearance. There was no scarring or permanent depigmentation of the skin in any subject. The study demonstrated that the StarLight Pulsed Diode Array Laser System is a safe and effective tool for the treatment of leg veins.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
PhotoGenica LPIR™
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
974346
JAN 1 6 1998
Attachment 9
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the StarLight™ Pulsed Diode Array 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: | Star Medical Technologies, Inc. |
|---|---|
| Address: | 1249 Quarry Lane, Suite 100 |
| Pleasanton, CA 94566 | |
| Contact Person: | Robert E. Grove, Ph.D. |
| Telephone: | (510) 484-2140 |
| Preparation Date: | November 14, 1997 |
| Device Trade Name: | StarLight™ Pulsed Diode Array Laser System |
| Common Name: | Pulsed Diode Array Laser |
| 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: | PhotoGenica LPIR™ |
| Cynosure, Inc. | |
| System Description: | The StarLight system delivers pulsed infrared laser light |
| with a wavelength of 800 nm, a selectable pulse duration of | |
| 5 - 30 ms, and a selectable fluence of 10 – 40 J/cm². The | |
| corresponding pulse energy delivered through the 9 x 9 mm | |
| handpiece tip is 8 – 32 J. The laser pulses are generated at a | |
| maximum pulse repetition frequency of 1 Hz by an array of | |
| diode lasers located in the handpiece. |
1
| | The complete system consists of a console, a footswitch,
and a handpiece connected to the console with an
umbilical. In standard use, the handpiece is pressed against
the patient's skin and a light pulse is delivered when the
footswitch and handpiece trigger are depressed. The
handpiece tip is water-cooled to provide active skin
cooling. Laser parameters and other system features are
controlled from the touch-screen on top of the console,
which provides an interface to the system computer. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device: | The StarLight Pulsed Diode Array Laser System is intended
for the treatment of leg veins in Dermatology and Plastic
Surgery procedures. |
| Performance Data: | Clinical studies were conducted to provide assurance that
differences in the specifications of the StarLight system and
the predicate device do not result in different performance
or raise new questions of safety or efficacy. |
| Results of Clinical Study: | Observations of vessel clearing and skin responses
were recorded as a function of vessel and treatment
parameters. Vessel effects included reduction in vessel
diameter, vessel coagulation, and vessel disappearance.
There was no scarring or permanent depigmentation of the
skin in any subject. The study demonstrated that the
StarLight Pulsed Diode Array Laser System is a safe and
effective tool for the treatment of leg veins. |
| Conclusion: | Based on the foregoing, the StarLight Pulsed Diode Array
Laser System is substantially equivalent to the legally-
marketed claimed predicate device for the purposes of this
510(K) submission. |
1000 100
·
: 上一篇:
2
Image /page/2/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
JAN 16 1998
Star Medical Technologies, Incorporated "C/O Ms. Marcy Moore Manager of Clinical Studies 9516 Candor Oaks Drive Raleigh, North Carolina 27615
Re: K974346
Trade Name: StarLight™ Pulsed Diode Array Laser System Regulatory Class: II Product Code: GEX Dated: November 14, 1997 Received: November 19, 1997
Dear Ms. Moore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
3
Page 2 - Ms. Moore
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K974346
INDICATION FOR USE STATEMENT
510(K) Number: Pending
StarLight™ Pulsed Diode Array Laser System Device Name:
Indications for Use:
. ·
The StarLight™ Pulsed Diode Array Laser System is intended for the treatment of leg veins in Dermatology and Plastic Surgery procedures.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
Prescription Use
OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)