SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER

K040289 · Cynosure, Inc. · GEX · Apr 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040289
• Device Name: SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
• Applicant: Cynosure, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 .

Device Story

SmartLite D is a frequency-doubled Nd:YAG laser (532 nm wavelength) utilizing a Nd:YAG crystal rod as the lasing medium. Device is operated by a physician or dentist via footswitch. It performs ablation, incision, excision, coagulation, and vaporization of soft tissue. The laser energy is delivered to the target site to achieve the desired surgical or therapeutic effect. The device is a compact unit (10 kg, 27x26x36 cm) intended for clinical use. It provides a surgical tool for various soft tissue procedures and dental applications, including tooth whitening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Frequency-doubled Nd:YAG laser; 532 nm wavelength; Nd:YAG crystal rod medium; footswitch activation; 230 VAC, 15A, 50-60 Hz power; 10 kg weight; 27x26x36 cm dimensions.

Indications for Use

Indicated for ablation, incision, excision, vaporization, and coagulation of soft tissue in ophthalmology, ENT, dermatology, and dentistry (including specific oral lesions, gingival procedures, and tooth whitening).

Regulatory Classification

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.

Predicate Devices

• Fisma Elite Family of Lasers, frequency doubled Nd:YAG
• Fisma Dental 200
• Fisma Dental 300
• Fisma Dental 400

Submission Summary (Full Text)

{0}------------------------------------------------

APR 3 0 2004

K 040289

## 510(K) Summary

| Submitter: | Cynosure, Inc.<br>10 Elizabeth Drive<br>Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho<br>Senior 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, laser<br>79-GEX<br>21 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:YAG<br>crystal rod as the lasing medium. It is a laser with a wavelength of<br>532 nm. |
| | Laser activation is by footswitch. Overall weight of the laser is 10 Kg<br>and 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,<br>coagulation and vaporization of tissue in ophthalmology, dermatology,<br>ENT & dentistry. |
| Comparison: | The SmartLite D laser has an equivalent indication for uses, the same<br>principle of operation, the same wavelength and essentially the same<br>pulse 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 the<br>intended uses. |
| Additional Information: | none |

{1}------------------------------------------------

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.

{2}------------------------------------------------

## 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

{3}------------------------------------------------

## 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