WAVELIGHT SINON

K050218 · Wavelight Laser Technologie AG · GEX · Feb 15, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050218
• Device Name: WAVELIGHT SINON
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions. 2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

Device Story

SINON is a 694 nm Ruby laser system. Operates in two modes: Q-Switch (QS) and Free-Running. QS mode delivers short pulse widths (ns) and high peak power (MW) for tattoo removal and pigmented lesion treatment. Free-Running mode used for hair removal. Operated by healthcare professionals in clinical settings. Laser energy interacts with target tissue to achieve ablation or hair removal. Device provides therapeutic benefit through precise tissue interaction.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

694 nm Ruby laser system. Dual operating modes: Q-Switch (nanosecond pulse width, megawatt peak power) and Free-Running. Class II surgical laser.

Indications for Use

Indicated for cutting, vaporization, or ablation of soft tissue (tattoos, benign pigmented lesions) via Q-Switch mode; removal of unwanted hair via Free-Running mode in patients with Fitzpatrick skin types I and II.

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

• SINON (K040433)
• Aesculap-Meditec RubyStar Laser System (K991285)
• Spectrum Medical Technologies RD-1200 (K910422)
• MLT Laser Technologies Inc. MLT R694 (K9909002)
• Mehl/Biophile Inc. Chromos 694 (K971814)
• WaveLight SINON (K040384)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "K 050218" above the WaveLight logo. The WaveLight logo consists of three horizontal wavy lines stacked on top of each other, followed by the word "WaveLight" in a sans-serif font. A registered trademark symbol is present to the right of the word "WaveLight".

#### 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

| Submitter: | WaveLight Laser Technologie, AG<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alexander Popp<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | December 16, 2004 |
| 2. Names | |
| Device Name: | SINON |
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>Panel: Dermatology and Plastic Surgery |

#### 3. Predicate Devices

This submission refers to the SINON device registered under 510(k) number K040433. Therefore the SINON described here is substantially equivalent to the SINON registered under 510(k) number K040433.

The SINON laser system is furthermore substantially equivalent to the Aesculap-Meditec RubyStar Laser System with Normal and Q-Switch Mode (K991285), the Spectrum Medical Technologies RD-1200 (K910422), the MLT Laser Technologies Inc. MLT R694 (K9909002), the Mehl/Biophile Inc. Chromos 694 (K971814) and WaveLights SINON device (K040384).

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#### 510(k) Summary of Safety and Effectiveness

#### 4. Device Description

The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.

## 5. Indications for Use

The SINON is indicated:

- 1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
- 2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
- 6. Performance Data

None presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2005

Wavelight Laser Technologie AG c/o Mr. Morten S. Christensen Underwriters Laboratories, Inc. 1655 Scott Boulevard Santa Clara, California 95050

Re: K050218 Trade/Device Name: SINON 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: January 25, 2005 Received: January 31, 2005

Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(tr) prematice is substantially equivalent (for the indications referenced above and nave uctoringed in active acted predicate devices marketed in interstate for use stated in the cherosule) to regars mannet date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enations with the provisions of the Federal Food. Drug. devices that have been reclassified in accessful of a premarket approval application (PMA). and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merclore, manel the act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (soc aborto) ins existing major regulations affecting your device can may be subject to such additional controlier is more of Parts 800 to 898. In addition, FDA may be found in the Ood of Peaces one ming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a baces in other requirements of the Act
that FDA has made a determination that your device complies with other requirements of the A that FDA has made a decemmation and your are your are Federal agencies. You must or any Federal statutes and regarations and limited to: registration and listing (21 comply with an the Act 3 requirements, n.c., good manufacturing practice requirements as set CFR Part 807), adoling (21 OFRT art 820); and if applicable, the electronic forin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Morten S. Christensen

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whi anow you to begin matteeing your antial equivalence of your device to a legally premarket nothleation: The PDA maing of basification 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 If you desire specific advice for your do 11 - 11 - 11 5. Also, please note the regulation entitled, Colliation of Compulance and (21 the Part 807.97). You may obtain Misoranting of Telefonoe to prementovnibilities under the Act from the Division of Small other general information on your respended its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Wilkerson

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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# ど WaveLight®

20

# 510 (k) Indication for Use

| 510(k) Number (if known): | K050218 | Indications for Use |
|---------------------------|---------|---------------------|
| Device Name: | SINON | |

# Indications for Use:

- 1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
- 2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------------|---|
| AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) | |

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

for Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| Page | 1 of 1 |
|---------------------------|--------|
| (indication for use only) | |

| 510(k) Number | K050218 |
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