CYNOSURE ERASURE LASER by CYNOSURE, INC.

The provided text is a 510(k) summary for the Cynosure Erasure Pulse Dye Laser. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel device performance through extensive clinical studies. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies is largely not applicable to this specific document.

Here's an breakdown based on the information provided in the 510(k) summary:

Acceptance Criteria and Reported Device Performance: This document does not describe specific performance-based acceptance criteria or report performance metrics from a study designed to meet such criteria. The basis for approval is substantial equivalence to a predicate device.
Sample Size for Test Set and Data Provenance: Not applicable. No test set or clinical data was provided. The submission states "Clinical Performance Data: None."
Number of Experts and Qualifications: Not applicable. No ground truth was established from experts for a test set.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No such study was conducted or reported. The document explicitly states "Clinical Performance Data: None."
Standalone (Algorithm Only) Performance Study: Not applicable. This is a laser device, not an algorithm.
Type of Ground Truth Used: Not applicable. No ground truth was established for performance evaluation.
Sample Size for Training Set: Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.
How Ground Truth for Training Set Was Established: Not applicable.

Summary based on the provided 510(k) document:

The Cynosure Erasure Pulse Dye Laser was approved based on its substantial equivalence to the Cynosure PhotoGenica VLS Laser. The comparison was based on:

Treatment wavelengths
Pulse duration
Pulse energy
Biological effects

The 510(k) summary explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None." This means the manufacturer did not submit specific performance studies with acceptance criteria, sample sizes, or ground truth to demonstrate the device's efficacy or safety beyond the comparison to the predicate device. The FDA's review concluded that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to proceed to market under general controls.

Summary

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JAN 20 1999

Kay 4517

510(K) Summary

Cynosure, Inc. Submitter: 10 Elizabeth Drive Chelmsford, MA 01824 George Cho Contact: Senior Vice President of Medical Technology December 18, 1998 Date Summary Prepared: Erasure Pulse Dye Laser Device Trade Name: Medical Laser System Common Name: Instrument, surgical, powered, laser Classification Name: 79-GEX 21 CFR 878.48 Cynosure PhotoGenica VLS Laser Equivalent Device: The Erasure Laser consists of three interconnected sections: the power Device Description: supply, the water cooling system and the optical path. Benign cutaneous vascular and vascular dependent lesions. Intended Use: The Erasure Laser is substantially equivalent to the Cynosure Comparison: PhotoGenica VLS Laser in terms of treatment wavelengths, pulse duration, pulse energy, and biological effects. Nonclinical Performance Data: None Clinical Performance Data: None The Cynosure Erasure Laser is another safe and effective laser for Conclusion: vascular and vascular dependent lesions. Additional Information: None requested at this time

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1999

Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K984517

Trade Name: Cynosure Erasure Pulse Dye Laser Regulatory Class: II Product Code: GEX Dated: December 18, 1998 Received: December 21, 1998

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 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 (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. George Cho

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 vour 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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Kapus | 510(k) Number (if known):

Device Name: Cynosure Erasure Pulse Dye Laser

Indications For Use:

The Erasure laser is used for the treatment of benign vascular and vascular dependent lesions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	4984517

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(Optional Format 1-2-96)

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.