CYNOSURE PHOTOGENICA 532 LASER by CYNOSURE, INC.

The PhotoGenica 532 Laser is a CW, frequency-doubled Nd:YAG laser system with a wavelength at 532 nm. The treatment beam output for the PhotoGenica 532 is 4 watts CW at 532 nm. The aiming beam is provided by 5 mW, 670 nm diode laser. Exposure times for the PhotoGenica 532 (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0 and continuous. Laser activation is by a footswitch. Overall weight of the unit is 25 lb (11 kg). Electrical power requirement is 120/230 VAC ±10%, 5/3 Amps, 50-60 Hz. The system is air-cooled by fans. Accessories available for use with the PhotoGenica 532 include 0.2, 0.5, 0.7, 1.0 and 1.5 mm (spot diameter) handpieces.

AI/ML Overview

The provided 510(k) summary for the Cynosure PhotoGenica 532 Laser does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

This 510(k) submission is a "premarket notification" for substantial equivalence. The device is being compared to a predicate device (American Medical Laser Nuvo-Lase 660 Laser) based on its technical characteristics (wavelength, power, pulse duration) and intended use. The focus of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed device, rather than proving its performance against specific quantitative acceptance criteria through a clinical study.

Here's a breakdown of why the requested information is not present based on the provided document:

A table of acceptance criteria and the reported device performance: This information is not provided. The submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described, as no clinical or nonclinical performance data was submitted.
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): Not applicable, as no test set or expert ground truth establishment is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is mentioned.
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 system, not an AI-assisted diagnostic tool, and no MRMC study or AI integration is described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for performance evaluation.
The sample size for the training set: Not applicable, as this is a physical medical device and not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable, as this is a physical medical device and not a machine learning algorithm.

In summary, the 510(k) for the Cynosure PhotoGenica 532 Laser is based on demonstrating substantial equivalence to a predicate device through a comparison of technical specifications and intended use, rather than through clinical performance studies against specific acceptance criteria.

Summary

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K974900

510(K) Summary FEB 2 7 1998

Submitter:	Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824
Contact:	George ChoSenior Vice President of Medical Technology
Date Summary Prepared:	December 24, 1997
Device Trade Name:	PhotoGenica 532 Laser
Common Name:	Medical Laser System
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48
Equivalent Device:	American Medical Laser Nuvo-Lase 660 Laser
Device Description:	The PhotoGenica 532 Laser is a CW, frequency-doubled Nd:YAGlaser system with a wavelength at 532 nm. The treatment beam outputfor the PhotoGenica 532 is 4 watts CW at 532 nm.
	The aiming beam is provided by 5 mW, 670 nm diode laser. Exposuretimes for the PhotoGenica 532 (in seconds) are 0.02, 0.05, 0.1, 0.25,0.5, 1.0 and continuous.
	Laser activation is by a footswitch. Overall weight of the unit is 25 lb(11 kg).
	Electrical power requirement is 120/230 VAC ±10%, 5/3 Amps, 50-60Hz. The system is air-cooled by fans.
	Accessories available for use with the PhotoGenica 532 include 0.2,0.5, 0.7, 1.0 and 1.5 mm (spot diameter) handpieces.
Intended Use:	The PhotoGenica 532 Laser system is indicated for the treatment ofvascular and pigmented lesions of the skin.
Comparison:	The PhotoGenica 532 Laser is substantially equivalent to the Nuvo-Lase 660 Laser in terms of treatment wavelength, pulse duration,power, and biological effects.
Nonclinical Performance Data:	none
Clinical Performance Data:	none
Conclusion:	The PhotoGenica 532 Laser is another safe and effective way to treat vascular or pigmented lesions of the skin.
Additional Information:	None requested at this time

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Mr. George Cho Senior Vice President Cynosure, Incorporated 10 Elizabeth Drive Chelmsford, Massachusetts 01824

Re : K974900 Cynosure PhotoGenica 532 Laser Trade Name: Regulatory Class: II Product Code: GEX 1997 Dated: December 24, December 30, 1997 Received:

Dear Mr. Cho:

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 The general controls provisions of the Act 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 Requlations, 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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. Cho

This letter will allow you to beqin 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,

Witten, Ph.D., M.D. Celi a M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _ Cynosure PhotoGenica 532 Laser

Indications For Use:

The PhotoGenica 532 laser is indicated for the treatment of benign cutaneous vascular and pigmented lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

pcoolfo

(Division Sign-Om)
Division of General Restorative Devices K974900
510(k) Number

Over-The-Counter Use_

Regulation Number and Section

§ 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.