(190 days)
The LightSheer™ is intended to effect temporary hair reduction in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV 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™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 3 and 20 milliseconds. Energy fluences of 10-60 J/cm² are achieved under conditions of intended use. A thermoelectrically cooled handpiece is held firmly against the treatment site.
The provided document is a 510(k) summary for the LightSheer™ Long Pulse Ruby Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a traditional clinical trial report would.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not applicable or not provided by this type of regulatory submission.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices for the specified indications for use.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| (Not explicitly stated as quantitative acceptance criteria) | "effective for producing a stable long-term, permanent reduction of hair." (Conclusion statement) | The device is deemed "effective" for its intended use, based on its characteristics being substantially equivalent to predicates that have established effectiveness. No specific %> reduction or success rate is provided as an acceptance criterion or performance measure. |
| Intended Use: - Temporary hair reduction in skin types I-IV - Stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. (Permanent hair reduction defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.) | The 510(k) cleared the device for these specific Indications for Use. | Clearance implies the FDA found sufficient evidence (through substantial equivalence) that the device can achieve these intended effects. |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- Not provided. The document states "Clinical Data: None required," indicating that a separate clinical efficacy study with a test set was not submitted for this 510(k) clearance. Clearance was based on substantial equivalence to predicate devices and engineering/performance data (though not detailed here).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As no clinical efficacy study with a test set was required/submitted, there was no need for experts to establish ground truth for such a set.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical efficacy study with a test set.
-
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:
- Not applicable. This device is a laser for hair reduction, not an AI-assisted diagnostic imaging device that would typically involve human "readers" or an MRMC study.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (laser system), not an algorithm or AI. Its performance is inherent to its physical operation, not an automated interpretation without human involvement. Humans operate the device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated as generated for this submission. The regulatory decision is based on a determination of substantial equivalence to predicate devices which presumably had their effectiveness established historically, potentially through clinical outcomes data or other means suitable for their time of clearance. For this specific 510(k), no new "ground truth" for a performance study was generated.
-
The sample size for the training set:
- Not applicable. This device is hardware (laser system), not a machine learning algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary of Regulatory Approach:
This 510(k) submission for the LightSheer™ Long Pulse Ruby Laser gained market clearance through the "substantial equivalence" pathway. This means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device (in this case, other LightSheer™ models and the EpiLaser® Normal Mode Ruby Laser). This pathway often does not require new clinical efficacy studies if the technological characteristics and indications for use are sufficiently similar to the predicate. The statement "Clinical Data: None required" confirms this approach for this particular submission.
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8/4/99
Kg82980
Attachment 2
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the LightSheer™ Long Pulse Ruby 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: | Palomar Medical ProductsAnthony Fiorillo, President | |
|---|---|---|
| Address: | 45 Hartwell AvenueLexington, MA 02781-676-7300 | |
| Contact Person: | Marcy MooreManager of Clinical Studies | |
| Telephone: | 919-676-7166 | |
| Fax: | 919-676-3683 | |
| Preparation Date: | August 24, 1998 | |
| Device Trade Name: | LightSheer™ Long Pulse Ruby Laser | |
| Common Name: | Ruby Laser, long pulse | |
| 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™ Long Pulse Ruby LaserPalomar Medical ProductsK980420EpiLaser® Normal Mode Ruby LaserPalomar Medical ProductsK980517 | |
| System Description: | The LightSheer™ operates at a wavelength of 694.3nanometers and the beam has a pulse duration of 3and 20 milliseconds. Energy fluences of 10-60 J/cm² |
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are achieved under conditions of intended use. A
thermoelectrically cooled handpiece is held firmly
against the treatment site.
| Intended Use of the Device: | The LightSheer™ is intended to effect temporaryhair reduction in skin types I-IV. The LightSheer™is also intended to effect stable long-term, orpermanent, hair reduction in skin types I-IV throughselective targeting of melanin in hair follicles.Permanent hair reduction is defined as a long-termstable reduction in the number of hairs regrowingafter a treatment regime. |
|---|---|
| Performance Data: | There are no technological differences. |
| Clinical Data: | None required. |
| Conclusion: | Based on the foregoing, the LightSheer™ is effectivefor producing a stable long-term, 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Products, Inc. 9516 Candor Oaks Drive Raleigh, North Carolina 27615
K982980 Trade Name: LightSheer™ Long Pulse Ruby Laser Regulatory Class: II Product Code: GEX Dated: January 11, 1999 Received: January 12, 1999
Dear Ms. Moore:
Re:
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 (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 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,
Stipt Rivelo
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: _______________________________________________________________________________________________________________________________________________________________
Device Name: LightSheer ™ Long Pulse Ruby Laser
Indications for Use:
The LightSheer™ is intended to effect temporary hair reduction in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanim 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)
| Prescription Use | X |
|---|---|
| ------------------ | --------------------------------------------------- |
OR Over-the-Counter Use
(per 21 CFR,801,109)
Stpt. K982980
(Division-Off)
Division of General Restorative Devices
513(k) Number
§ 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.