CYNERGY MULTIPLEX LASER by CYNOSURE, INC.

1,064nm: The Cynergy laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lakes, leg veins, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café au lait manules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is intended for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).

585 - 600nm with 1,064mm Wavelength Multiplex Mode: The wavelength multiplex mode is intended for benign vascular and vascular dependant lesions removal.

Device Description

The Cynergy Multiplex laser is user selectable, multi wavelength laser, having both an organic dye and an Nd:YAG rod lasing medium. It is a pulsed dye laser with wavelengths of 585, 590, 595, 600 nm and an Nd:YAG laser with a wavelength of 1,064 nm. It is capable of delivering one wavelength pulse or mixing of two wavelengths pulse.

Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD).

Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.

AI/ML Overview

The provided text is a 510(k) summary for the Cynosure Cynergy Multiplex Laser, which is a medical laser system. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for novel performance claims.

Therefore, the document explicitly states:

"Nonclinical Performance Data: none"
"Clinical Performance Data: none"

Given this, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text. The regulatory submission relies on the established safety and effectiveness of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
None specified as this is a substantial equivalence submission without new clinical data.	N/A (No new performance data reported)

Summary

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JUN 27 2005

510(K) Summary

Submitter:	Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824
Contact:	George ChoSenior Vice President of Medical Technology
Date Summary Prepared:	March 25, 2005
Device Trade Name:	Cynergy Multiplex Laser
Common Name:	Medical Laser System
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48
Equivalent Device:	Cynosure Cynergy laser
Device Description:	The Cynergy Multiplex laser is user selectable, multi wavelength laser,having both an organic dye and an Nd:YAG rod lasing medium. It is apulsed dye laser with wavelengths of 585, 590, 595, 600 nm and anNd:YAG laser with a wavelength of 1,064 nm. It is capable ofdelivering one wavelength pulse or mixing of two wavelengths pulse.Laser activation is by footswitch. Overall weight of the laser is 285lbs,and the size is 44"x19"x24" (HxWxD).Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, singlephase.
Intended Use:	The Cynergy Multiplex is indicated for treatment of vascular lesions,pigmented lesions, tattoos, wrinkles and hair removal.
Comparison:	The Cynergy Multiplex laser is substantially equivalent to the predicatelaser with the same principle of operation, and similar wavelengths andfluence ranges as the predicate devices.
Nonclinical Performance Data:	none
Clinical Performance Data:	none
Conclusion:	The Cynergy Multiplex laser is another safe and effective device fortreating vascular lesions, pigmented lesions, tattoos, wrinkles and hairremoval.
Additional Information:	none

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 2005

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

Re: K050779

Trade/Device Name: Cynosure Cynergy Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 25, 2005 Received: March 28, 2005

Dear Mr. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 too stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de necs mat have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (Act) that do not requent openeral controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of gencial controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your acviec is elassified (660 ac v) strols. Existing major regulations affecting your device and It may be subject to sadh additions, Title 21, Parts 800 to 898. In addition, FDA can oc found in the Oods of reasureming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc devised that I Dri brosams of your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must or any it call the Act's requirements, including, but not limited to: registration and listing (21 comply will an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevens (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. George Cho

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icter will anow you to oogin maing of substantial equivalence of your device to a legally premarket notification: "The Pels 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), please If you desire specific acries in 1 2 = 0 15 . Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Name of Manufacturer: Cynosure, Inc.

Laser Model Name and Number: CYNERGY MULTIPLEX LASER for surgery and dermatology.

Laser Type: (Circle all that apply) Laser Type. (Onele an alar app.) Diode, Dye Old: YAG, Erbium, Hol:YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other _______________________________________________________________________________________________________________________________

Indications in this application: Treatment of vascular lesions, pigmented lesions, tattoos, wrinkles and hair removal when a single wavelength pulse is delivered. In the multiplex mode, only benign vascular and vascular dependent lesion removals are indicated.

FDA Document Control Number: K050779/A1

FDA Product Code: 79GEX

Reviewer Computer Initials: ABC

Date of Clearance Letter: 6/22/05

Basis of Approval: (Circle all that apply) Dasts of Approval. (Sirely and apply)
Predicate Device (PD) Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other __________________________________________________________________________________________________________________________

Description of Laser: The system is a user selectable, multi-wavelength laser including both an Deseription of Labor VAG rod lasing medium. It is capable of delivering one wavelength pulse or a combination of two wavelength pulses (PDL followed by Nd: YAG).

Operation-Modes: (Circle all that apply) CW, Pulsed, Q Switched, Mode Locked, Contact, Free Beam, Other _______________________________________________________________________________________________________________

Wavelength in Nanometers: 1064; 585, 590, 595 & 600; capable of mixing two wavelengths.

Power/Energy Range (Watts/Joules): max 25 J/cm² (PDL); 300 J/cm² (Nd:YAG)

Pulse Width: 0.5-40 ms (PDL); 0.5-300 ms (Nd: YAG)

Repetition Rate: Single: 1-2 Hz (PDL); 1-10 Hz (Nd:YAG)

Delivery System: Single optical fiber (lens-coupled quartz), one for each head, and hand pieces with spot sizes ranging from 4.8-12.3 mm (PDL) or 2.8-15.3 mm (Nd:YAG)

Comments: The delay times between two pulses can range from 20-2000 ms. In the absence of new clinical data for multiplex applications, only removal of benign vascular and vasculardependent lesions is indicated for the multiplex mode.

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _ Cynosure Cynergy Laser

Indications For Use:

585 - 600nm: The Cynergy laser is indicated for benign vascular and vascular dependant lesions removal.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

585 - 600nm with 1,064mm Wavelength Multiplex Mode: The wavelength multiplex mode is intended for benign vascular and vascular dependant lesions removal.

OR Prescriptive Use X X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Vising " Division of Center, I Destrative and Neur Slogical L

050779

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.