(230 days)
Not Found
No
The device description focuses on the laser technology and its parameters, with no mention of AI or ML. The performance studies evaluate the clinical outcome of the laser treatment, not the performance of any AI/ML algorithm.
No
The device is intended for temporary, stable long-term, or permanent hair reduction, not for diagnosing, curing, mitigating, treating, or preventing disease, injury, or other conditions.
No
The device is described as affecting temporary or permanent hair reduction, not as diagnosing any condition or disease.
No
The device description explicitly states it delivers pulsed infrared laser light and includes a handpiece with diode lasers and water-cooling, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to effect temporary hair reduction" and "stable long-term, or permanent, hair reduction". This is a therapeutic or cosmetic application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device delivers laser light to the skin. This is an external application, not a process involving analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, the LightSheer™ device, as described, is a medical device used for hair reduction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Product codes
GEX
Device Description
The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2. 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 handpiece tip is water-cooled to provide active skin cooling.
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)
Observations of hair and skin responses were recorded prior to treatment and at 1, 3, 6, 9, and 12 months after treatment. There was no scarring or permanent skin injury in any subject. The study demonstrated that LightSheer™ is a safe and effective tool for permanent hair reduction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
4/SICCI
Attachment 4
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the LightSheer™ Pulsed Diode Array Laser 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.
Robert E. Grove, Ph.D., President |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1249 Quarry Lane
Pleasanton, CA |
| Contact Person: | Marcy Moore
Manager of Clinical Studies |
| Telephone: | 919-676-7166 |
| Fax: | 919-676-3683 |
| Preparation Date: | August 17, 1998 |
| Device Trade Name: | LightSheer™ Pulsed Diode Array Laser |
| Common Name: | LightSheer™ Diode Laser System |
| 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: | LightSheer™ Pulsed Diode Array Laser
Star Medical Technologies, Inc.
K973324 |
| System Description: | The LightSheer™ delivers pulsed infrared laser light
with a wavelength of 800 nm, a selectable pulse
duration of 5 - 30 ms, and a selectable pulse energy
of 8 - 32 J. The corresponding fluence delivered
through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2.
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 handpiece tip is
water-cooled to provide active skin cooling. |
| Intended Use of the Device: | The LightSheer™ is intended to effect temporary
hair reduction. The LightSheer® is also intended to
effect stable long-term, or permanent, hair reduction
through selective targeting of melanin in hair
follicles. Permanent hair reduction is defined as a
long-term stable reduction in the number of hairs
regrowing after a treatment regime. |
| Performance Data: | There are no technological differences. |
| Results of Clinical Study: | Observations of hair and skin responses were
recorded prior to treatment and at 1, 3, 6, 9, and 12
months after treatment. There was no scarring or
permanent skin injury in any subject. The study
demonstrated that LightSheer™ is a safe and
effective tool for permanent hair reduction. |
| Conclusion: | Based on the foregoing, the LightSheer™ is effective
for producing a long-term stable, permanent
reduction of hair. |
1
:
.
.
2
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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 8 1099
Star Medical Technologies, Inc c/o Ms. Marcy Moore Manager of Clinical Studies 9516 Candor Oaks Drive Raleigh, North Carolina 27615
K982940 Re:
Trade Name: LightSheer™ Pulsed Diode Array Laser System Regulatory Class: II Product Code: GEX Dated: February 1, 1999 Received: February 3, 1999
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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Marcy Moore
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,
Celia 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
INDICATION FOR USE STATEMENT
510(k) Number: _ 上 982940 ______________________________________________________________________________________________________________________________________________________________________________
Device Name: LightSheer™ Pulsed Diode Array Laser
Indications for Use:
The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
(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 | |
510(k) Number | K982940 |
Prescription Use (per 21 CFR 801.109) | X | OR | Over-the-Counter Use |
---|---|---|---|
--------------------------------------- | --- | ---- | ---------------------- |