(230 days)
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.
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.
The provided text describes the LightSheer™ Pulsed Diode Array Laser, which is intended for hair reduction. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Intended Use) | Reported Device Performance (Results of Clinical Study) |
|---|---|
| Effect temporary hair reduction. | The study demonstrated that LightSheer™ is a safe and effective tool for permanent hair reduction. (Implying temporary reduction would also be achieved) |
| Effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. | The study demonstrated that LightSheer™ is a safe and effective tool for permanent hair reduction. "Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime." |
| No scarring or permanent skin injury. | There was no scarring or permanent skin injury in any subject. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of subjects or hair sites included in the clinical study. It only refers to "any subject."
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that it's a 510(k) submission for a new device claiming effectiveness for its intended use, it would typically be a prospective clinical trial conducted in the country of the applicant (USA, based on the address).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The clinical study describes "Observations of hair and skin responses were recorded," but it does not specify who made these observations or their qualifications.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a laser for hair reduction, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The LightSheer™ is a physical medical device (laser system), not a software algorithm. Its performance is inherent in its operation, not in an algorithm that could be run standalone.
7. The type of ground truth used
The ground truth appears to be direct observation of hair regrowth and skin responses by unspecified personnel. The definition of "permanent hair reduction" also serves as a ground truth criterion. There is no mention of pathology or other objective outcome data, beyond visual assessment of hair and skin.
8. The sample size for the training set
This information is not applicable/provided. As a physical device, there is no "training set" in the context of machine learning. The device's parameters (wavelength, pulse duration, energy, fluence, etc.) are designed based on scientific principles and prior research into laser-tissue interaction for hair removal, rather than on a data-driven training process.
9. How the ground truth for the training set was established
This information is not applicable/provided. As explained above, there is no "training set" for a physical laser device in the way there is for an AI algorithm. The scientific basis for its design would come from general knowledge of light absorption by melanin and tissue thermal damage, which is established through extensive scientific literature and research, not a specific "training set" with ground truth in the context of the regulatory submission.
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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 LanePleasanton, CA |
| Contact Person: | Marcy MooreManager 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 andPlastic Surgery and in Dermatology(see: 21 CFR 878-4810).Product Code: GEXPanel: 79 |
| Legally-Marketed Predicate Device: | LightSheer™ Pulsed Diode Array LaserStar Medical Technologies, Inc.K973324 |
| System Description: | The LightSheer™ delivers pulsed infrared laser lightwith a wavelength of 800 nm, a selectable pulseduration of 5 - 30 ms, and a selectable pulse energyof 8 - 32 J. The corresponding fluence deliveredthrough the 9 x 9 mm handpiece tip is 10 - 40 J/cm2.The laser pulses are generated at a maximum pulserepetition frequency of 1 Hz by an array of diode |
| lasers located in the handpiece. The handpiece tip iswater-cooled to provide active skin cooling. | |
| Intended Use of the Device: | The LightSheer™ is intended to effect temporaryhair reduction. The LightSheer® is also intended toeffect stable long-term, or permanent, hair reductionthrough selective targeting of melanin in hairfollicles. Permanent hair reduction is defined as along-term stable reduction in the number of hairsregrowing after a treatment regime. |
| Performance Data: | There are no technological differences. |
| Results of Clinical Study: | Observations of hair and skin responses wererecorded prior to treatment and at 1, 3, 6, 9, and 12months after treatment. There was no scarring orpermanent skin injury in any subject. The studydemonstrated that LightSheer™ is a safe andeffective tool for permanent hair reduction. |
| Conclusion: | Based on the foregoing, the LightSheer™ is effectivefor producing a long-term stable, permanentreduction of hair. |
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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.
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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
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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.
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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 |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
§ 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.