FOTONA SKINLIGHT PLUS ND: YAG SYSTEM

K972368 · Medical Laser Solutions · GEX · Sep 23, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972368
• Device Name: FOTONA SKINLIGHT PLUS ND: YAG SYSTEM
• Applicant: Medical Laser Solutions
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fotona Skinlight Plus Nd: YAG system is indicated for the photocoagulation of benign vascular and pigmented lesions.

Device Story

Fotona Skinlight Plus Nd:YAG system is an accessory sub-system added to a previously cleared Er:YAG laser (K962902). Device utilizes a Nd:YAG crystal activated by flashlamps within an optical cavity. A red diode aiming beam is reflected onto a coaxial path via a beamsplitter. Therapeutic and aiming beams are delivered through an optical fiber to a focusing handpiece for noncontact use. System emits up to 2.0 Watts at 532 nm with a minimum pulsewidth envelope of 100ms. Operated by clinicians in a medical setting for photocoagulation of benign vascular and pigmented lesions. The laser energy is absorbed by blood or melanin in soft tissue, allowing for precise tissue action. The device includes an electronic power supply and interface circuitry.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Nd:YAG laser system; 532 nm wavelength; 2.0 Watts output; 100ms minimum pulsewidth; optical fiber delivery system; focusing handpiece; electronic power supply; noncontact operation.

Indications for Use

Indicated for the photocoagulation of benign vascular and pigmented lesions.

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

• Laserscope Aura system (K951034)

Reference Devices

• Fotona Er:YAG system (K962902)

Submission Summary (Full Text)

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SEP 2 3 1997

Premarket notification : Fotona Nd: YAG Laser

972368

## Summary of Safety and Effectiveness Data Appendix E :

## General Information and Description

The Fotona Skinlight Plus system is based on the addition of a Nd: YAG accessory to a previously cleared Er: YAG system (K962902). Within the accessory sub-system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity,a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in noncontact mode.

The System is capable of emitting up to 2.0 Watts of light at 532 nm, with a minimal pulsewidth envelope of 100ms. The laser is intended to be used for the photocoagulation of benign vascular and pigmented lesions.

The Nd: YAG accessory sub-system is designed with 3 major sub-systems:

a) An optical fiber delivery system terminated in spot-size specific handpiece.

b) An electronic power supply and interface circuitry.

c) An optical chamber containing laser rod and laser cavity optics.

No accessories are available for use with the accessory Nd: Y AG sub-system.

## Summary of Substantial Equivalence

Fotona believes that its Skinlight Plus Nd: Y AG system is substantially equivalent to the Laserscope Aura system, previously cleared under K 951034.

The Fotona Skinlight Plus Nd: YAG system is intended for the photocoagulation of benign vascular and pigmented lesions. It therefore has the same Intended Use as the Laserscope Aura system.

Both of these lasers have a wavlength of 532nm. This wavelength is highly absorbed in soft tissue containing blood or melanin. Both lasers are therefore absorbed in an equally small volume of tissue, allowing for very precise action on the target tissue components.

Both lasers have a maximum average power capability of 10 Watts.

In terms of pulsewidth, both systems generate an envelope containing a series of individual pulses. In each case, an envelope width of 0.1 - 1.0 seconds may be preset. The envelope may also be extended to a continuous emission.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Fotona c/o Iain D. Miller, Ph.D. President Medical Laser Solutions 304 Newbury Street, #339 Boston, Massachusetts 02115

SEP 2 3 1997

Re: K972368

> Trade Name: Fotona Skinlight Plus Nd: YAG System Regulatory Class: II Product Code: GEX Dated: June 23, 1997 Received: June 25, 1997

Dear Dr. Miller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Iain D. Miller, Ph.D.

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S.J.M. Witt, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix F

Page_

510(k) Number (if known):_K972369 Skinlight Plus Nd : YAG system Device Name:_ otona

Indications For Use:

The Fotona Skinlight Plus Nd: YAG system is indicated for the photocoagulation of benign vascular and pigmented lesions.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------|
| (Division) Sign-Off) | |
| Division of General Restorative Devices | KG 72368 |
| 510(k) Number | |

Prescription Use /
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_
(Optional Format 1-2-96)