(36 days)
The SmoothLASE TM Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE TM Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
The SmoothLASE TM Alexandrite Laser System is a medical device which is capable of emitting an invisible treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. In addition to the standard pulse width of nominally 1 Msec at 1Hz, the SmoothLASE TM Alexandrite Laser System will operate up to 3 Hz. Additionally, a single pulse is modulated to provide 6 x 1 Msec pulses at 1.3 Hz.
The provided text is a 510(k) summary and FDA clearance letter for the SmoothLASE™ Alexandrite Laser System. It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria through performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, statistical analysis, and expert input is not present in the provided document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document primarily focuses on regulatory classification, safety features based on standards, and substantial equivalence to predicate devices. There are no specific performance metrics or acceptance criteria reported for device efficacy (e.g., hair removal effectiveness).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not present as no specific clinical study data (test set) is provided or referenced in detail for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not present as there is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not present.
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
This is not applicable as the device is a laser system for hair removal, not an AI-assisted diagnostic or interpretive tool. There are no human "readers" in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present as no specific study data or ground truth establishment is detailed. The basis for safety and effectiveness is stated as substantial equivalence to predicate devices.
8. The sample size for the training set
This information is not present as no training set for an algorithm is mentioned or relevant to this device.
9. How the ground truth for the training set was established
This information is not present.
Summary of available information related to safety and effectiveness:
While the document does not contain the detailed study information requested, it does state:
- Safety Features: "The safety features of the device have been designed in accordance with relevant standards such as BS EN 60825-1 (Safety of Laser Product) and BS EN 6061-2-22 (Medical Electrical Equipment Safety). The labeling complies with 21 CFR subchapter J for a Class IV laser product." This indicates adherence to established safety standards, which can be seen as meeting "acceptance criteria" for safety.
- Predicate Devices: The device is deemed "substantially equivalent" to the Cynosure PhotoGenica LPIR (K971737) and the Lambda LaseAway Alexandrite Laser distributed by Silver Creek Surgical (K982316). The FDA's finding of substantial equivalence implies that the device is considered as safe and effective as these previously cleared devices, which have presumably met their own acceptance criteria.
- Conclusion: "The SmoothLASE TM Alexandrite Laser System is safe and effective for the intended purpose of removal of unwanted body hair on adults 18 years of age or older." This conclusion is based on the substantial equivalence review.
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LEISEGANG MEDICAL, INC. 6401 CONGRESS AVENUE BOCA RATON, FLORIDA 33487-2883 (561) 994-0202 (800) 448-4450 FAX: (561) 998-0846
K 990043
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Date: | January 4, 1999 |
|---|---|
| Prepared By: | Loma K. Linville |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48, Class II |
| Proprietary Name: | SmoothLASE TM Alexandrite Laser System |
| Indications: | The SmoothLASE TM Alexandrite Laser is intended for thecosmetic removal of unwanted hair on adults (18 years or older).The SmoothLASE TM Alexandrite Laser System is intended foruse only by qualified physicians trained in the safe operation ofthe system. |
| Description: | The SmoothLASE TM Alexandrite Laser System is a medicaldevice which is capable of emitting an invisible treatment laserbeam at a wavelength of 755 nm under the guidance of a visibleaiming beam. In addition to the standard pulse width of nominally1 Msec at 1Hz, the SmoothLASE TM Alexandrite Laser Systemwill operate up to 3 Hz. Additionally, a single pulse is modulatedto provide 6 x 1 Msec pulses at 1.3 Hz. |
| Safety Features: | The safety features of the device have been designed inaccordance with relevant standards such as BS EN 60825-1(Safety of Laser Product) and BS EN 6061-2-22 (MedicalElectrical Equipment Safety). The labeling complies with 21 CFRsubchapter J for a Class IV laser product. |
| Predicate Devices: | The SmoothLASE TM Alexandrite Laser System issubstantially equivalent to numerous devices that are currentlycommercially available. These devices include the CynosurePhotoGenica LPIR (K971737) and the Lambda LaseAwayAlexandrite Laser distributed by Silver Creek Surgical (K982316). |
| Conclusion: | The SmoothLASE TM Alexandrite Laser System is safe andeffective for the intended purpose of removal of unwanted bodyhair on adults 18 years of age or older. |
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Image /page/1/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 top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 1999
Mr. Rahn F. Smith Product Manager, Diagnostic Division Leisegang Medical, Inc. 6401 Congress Avenue Boca Raton, Florida 33487-2883
Re: K990043 Trade Name: SmoothLASE™ Alexandrite Laser System Regulatory Class: II Product Code: GEX Dated: January 4, 1999 Received: January 6, 1999
Dear Mr. Smith:
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 - Mr. Rahn F. Smith
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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Page 1
510(k) Number (if Known): 上 9900 43
SmoothLASE Alexandrite Laser System Device Name:
Indications For Use:
1
The SmoothLASE Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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.