The Cynosure Apogee-TKS II Dermatological Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin.

It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Device Description

Cynosure Apogee-TKS II laser, having an Alexandrite crystal rod as the lasing medium. It is a laser with a wavelength of 755nm.

Laser activation is by either finger or foot switch. Overall weight of the laser is 45 Kg, and the size is 113x53x84 cm (HxWxD).

Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase.

AI/ML Overview

The provided 510(k) summary for the Cynosure Apogee-TKS II Laser does not contain any information about acceptance criteria or a study proving the device meets them.

Instead, the submission states:

Clinical Performance Data: none
Nonclinical Performance Data: none

This indicates that the device was cleared based on its substantial equivalence to a predicate device (Cynosure Apogee-TKS) without new clinical or non-clinical performance studies being submitted or required. Therefore, I cannot provide the requested information.

The FDA's letter further confirms this by stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

In summary, the provided document does not contain the study details, acceptance criteria, or performance data typically associated with a new device demonstrating efficacy and safety through clinical or non-clinical trials.

Summary

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K031488 1488 1

JUN - 4 2003

510(K) Summary

Submitter:	Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824
Contact:	George ChoSenior Vice President of Medical Technology
Date Summary Prepared:	May 9, 2003
Device Trade Name:	Cynosure Apogee-TKS II Laser
Common Name:	Medical Laser System
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48
Equivalent Device:	Cynosure Apogee-TKS
Device Description:	Cynosure Apogee-TKS II laser, having an Alexandrite crystal rod asthe lasing medium. It is a laser with a wavelength of 755nm.
	Laser activation is by either finger or foot switch. Overall weight ofthe laser is 45 Kg, and the size is 113x53x84 cm (HxWxD).
	Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase.
Intended Use:	The Cynosure Apogee-TKS II laser is indicated for permanent hairreduction and the treatment of vascular lesions, pigmented lesions andwrinkles.
Comparison:	The Cynosure Apogee-TKS II laser is substantially equivalent to thepredicate devices, with the same principle of operation, the samewavelength and essentially the same power range and the sameindications for uses.
Nonclinical Performance Data:	none
Clinical Performance Data:	none
Conclusion:	The Cynosure Apogee-TKS II laser is another safe and effectivedevice for permanent hair reduction and treatment of vascular lesions,pigmented lesions and wrinkles.
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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

JUN - 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031488 Trade/Device Name: Cynosure Apogee-TKS II 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: May 9, 2003 Received: May 13, 2003

Dear Mr. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. 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/dsma/dsmamain.html

Sincerely vours.

sincerely, yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _KO3 | 488

Image /page/3/Picture/1 description: The image shows a handwritten number sequence. The numbers are 6031488. The numbers are written in black ink on a white background. There is a line drawn underneath the numbers.

Device Name: Cynosure Apogee-TKS II Dermatological Laser

Indications For Use:

It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mellman

(Division Sign-Off) Division of General, Restorative ା Neurological Devices

) Number K031488

Prescription 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.