SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER by CYNOSURE, INC.

The SmartLite D laser device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue, in ophthalmology, ENT, and dermatology. In addition, the laser is intended for application in dentistry including:

Frenectomy .
Treatment of Oral Mucous Cysts .
Treatment of Benign Vascular Lesions .
Photocoagulation of Superficial Vessels .
Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels ●
Treatment of Superficial Tongue Lesions .
Tissue Management and Hemostasis for Crown and Bridge Impressions ◆
Incision and Drainage for Abscess .
Gingivoplasty / Gingivectomy .
Hemostasis during Dental Procedurcs .
Operculectomy (Operculotomy) .
Excisional Biopsy .
Free Gingival Graft (Adjunct) .
Vestibuloplasty .
Soft Gutta Percha .
Treatment of Canker sores, Herpetic Lesions, and Aphthous Ulcers
Laser-assisted Bleaching / Whitening of the Teeth .

Device Description

SmartLite D is a frequency doubled Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 532 nm. Laser activation is by footswitch. Overall weight of the laser is 10 Kg and the size is 27x26x36 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

AI/ML Overview

This 510(k) premarket notification for the Cynosure SmartLite D Laser does not include acceptance criteria or a study demonstrating the device meets such criteria because it is a traditional medical device (a laser system), not an AI/ML-powered device.

The provided document is a 510(k) summary for a medical laser system. For traditional medical devices like this, the demonstration of safety and effectiveness typically relies on substantial equivalence to a predicate device, as opposed to performance metrics against acceptance criteria derived from clinical studies or AI algorithm evaluation.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. Performance is assessed by demonstrating equivalence to a predicate.
Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI algorithm here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Instead, the relevant information for this 510(k) submission is:

Nonclinical Performance Data: "none"
Clinical Performance Data: "none"
Comparison: "The SmartLite D laser has an equivalent indication for uses, the same principle of operation, the same wavelength and essentially the same pulse energy range as the predicate devices."
Predicate Device: Fisma Elite Family of Lasers (frequency doubled Nd:YAG), Fisma Dental 200, Dental 300, Dental 400.

The FDA's decision to clear this device (K040289) was based on its determination of "substantial equivalence" to a legally marketed predicate device, as stated in the letter from the FDA. This means the device was found to be as safe and effective as the predicate device already on the market, based on similar indications for use, principle of operation, wavelength, and pulse energy range, rather than a specific performance study against defined acceptance criteria.

Summary

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APR 3 0 2004

K 040289

510(K) Summary

Submitter:	Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824
Contact:	George ChoSenior Vice President of Medical Technology
Date Summary Prepared:	February 5, 2004
Device Trade Name:	SmartLite D Laser
Common Name:	Medical Laser System
Classification Name:	Instrument, surgical, powered, laser79-GEX21 CFR 878.48
Equivalent Device:	Fisma Elite Family of Lasers, frequency doubled Nd:YAG
	Fisma Dental 200, Dental 300, Dental 400
Device Description:	SmartLite D is a frequency doubled Nd:YAG laser, having a Nd:YAGcrystal rod as the lasing medium. It is a laser with a wavelength of532 nm.
	Laser activation is by footswitch. Overall weight of the laser is 10 Kgand the size is 27x26x36 cm (HxWxD).
	Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
Intended Use:	The SmartLite D is indicated for ablation, incision, excision,coagulation and vaporization of tissue in ophthalmology, dermatology,ENT & dentistry.
Comparison:	The SmartLite D 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 SmartLite D laser is another safe and effective device for theintended uses.
Additional Information:	none

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Public Health Service

APR 3 0 2004

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: K040289 Trade/Device Name: SmartLite D 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: February 5, 2004 Received: February 6, 2004

Dear Mr. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(x) proxice is substantially equivalent (for the indications felerenced above and nave uctorinmed the end predicate devices marketed in interstate for use stated in the enclosure) to regard cate of the Medical Device Amendments, or to commerce proof to May 20, 1976, the eccordance with the provisions of the Federal Food, DINEA devices that have tocer recuire approval of a premarket approval application (PMA). alla Cosmetic Act (Tec) that as novements with the general controls provisions of the Act. The 1 ou may, dierelore, market the act include requirements for annual registration, listing of general controls provincies practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can may oe sunyeet to back as 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 r lease be as made a determination that your device complics with other requirements of the Act than + Direcal statutes and regulations administered by other Federal agencies. You must or any I 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 OFF rate 8075 https://www.bg (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. 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,

Mark A. Melkersen

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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Indications for Use

04028 510(k) Number (if known):

Device Name: SmartLite D Laser

Indications For Use: The SmartLite D laser device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue, in ophthalmology, ENT, and dermatology. In addition, the laser is intended for application in dentistry including:

Frenectomy .
Treatment of Oral Mucous Cysts .
Treatment of Benign Vascular Lesions .
Photocoagulation of Superficial Vessels .
Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels ●
Treatment of Superficial Tongue Lesions .
Tissue Management and Hemostasis for Crown and Bridge Impressions ◆
Incision and Drainage for Abscess .
Gingivoplasty / Gingivectomy .
Hemostasis during Dental Procedurcs .
Operculectomy (Operculotomy) .
Excisional Biopsy .
Free Gingival Graft (Adjunct) .
Vestibuloplasty .
Soft Gutta Percha .
Treatment of Canker sores, Herpetic Lesions, and Aphthous Ulcers �
Laser-assisted Bleaching / Whitening of the Teeth .

Prescription Use (Part 21 CFR 801 Subpart D) OR

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

Mark A. Millman

(Division S Division of General. Restorative, and Neurological Levices

510(k) Number K040284

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.