CYNOSURE SMART FILE ND:YAG LASERS by CYNOSURE, INC.

The Smart File laser device is to provide the ability to perform intraoral soft tissue, general, and oral maxillo-facial surgery. The device is intended for ablation, incision, vaporization and coagulation of soft tissue using a contact, fiber optic delivery system. The device will be used in the folowing areas: general dentistry, otolaryngology, dermatology and plastic surgery.

Device Description

Smart File is a Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm. Laser activation is by footswitch. Overall weight of the laser is 38 Kg, and the size is 68x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

AI/ML Overview

The provided text is a 510(k) Summary for the Cynosure Smart File, Smart File 6, and Smarty A10 medical laser systems. It explicitly states in the "Nonclinical Performance Data" and "Clinical Performance Data" sections that there is "none".

Therefore, no acceptance criteria, study details, sample sizes, expert qualifications, or ground truth information related to device performance are present in the provided document. The device was found substantially equivalent based on its comparison to predicate devices in terms of indications for use, principle of operation, wavelength, and pulse energy range, rather than through clinical or nonclinical performance studies detailed in this summary.

Summary

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510(K) Summary

Submitter:	Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824
Contact:	George ChoSenior Vice President of Medical Technology
Date Summary Prepared:	April 9, 2003
Device Trade Name:	Smart File, Smart File 6, Smarty A10
Common Name:	Medical Laser System
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48
Equivalent Device:	Millennium PerioLase and Lares Research SunLase 800P
Device Description:	Smart File is a Nd:YAG laser, having a Nd:YAG crystal rod as thelasing medium. It is a laser with a wavelength of 1,064 nm.Laser activation is by footswitch. Overall weight of the laser is 38 Kg,and the size is 68x23x65 cm (HxWxD).Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
Intended Use:	The Smart File is indicated for ablation, incision, excision, coagulationand vaporization of intraoral soft tissue.
Comparison:	The Smart File laser has an equivalent indication for uses, the sameprinciple of operation, the same wavelength and essentially the samepulse energy range as the predicate devices.
Nonclinical Performance Data:	none
Clinical Performance Data:	none
Conclusion:	The Smart File laser is another safe and effective device for intraoralsoft tissue applications.
Additional Information:	none

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OCT - 9 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: K031125 Trade/Device Name: Cynosure Smart File Laser Smart File, SmartFile 6, Smarty A10 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: August 28, 2003 Received: August 29, 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, 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 (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) prematket 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. 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 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 yours.

Miriam C. Provost

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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K03125 510(k) Number (if known):

Device Name: __Cynosure Smart File Laser (Smart File, Smart File 6, Smarty A10)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

K 031125 510(k) Number -

Prescription Use

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.