SINON

K040433 · Wavelight Laser Technologie AG · GEX · May 19, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040433
• Device Name: SINON
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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 for dermatological applications. Operates in two modes: Q-Switch (QS) mode, utilizing extremely short pulse widths (nanoseconds) and high peak power (megawatts) for tattoo removal and benign pigmented lesion treatment; and Free-Running mode for hair removal. Device used in clinical settings by trained professionals. Laser energy is delivered to target tissue to achieve ablation or hair removal. System design and intended use are consistent with established Ruby laser technology for surgical and dermatological procedures.

Clinical Evidence

No clinical data presented.

Technological Characteristics

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

Indications for Use

Indicated for patients with Fitzpatrick skin types I and II for unwanted hair removal (Free-Running Mode) and for patients requiring cutting, vaporization, or ablation of soft tissue, including tattoo removal and treatment of benign pigmented lesions (Q-Switch Mode).

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

• 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)

Submission Summary (Full Text)

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K 040433

# 510(k) Summary of Safety and Effectiveness for the WaveLight Laser Technologie, AG SINON laser system

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: | Maureen O'Connell<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | February 10, 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

The SINON laser system is 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) and the Mehl/Biophile Inc. Chromos 694 (K971814).

#### 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 = 103s) 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.

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# 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 logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2004

WaveLight Laser Technologic, AG c/o Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K040433 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: February 13, 2004 Received: February 19, 2004

Dear Ms. O'Connell:

We have reviewed your Scction 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. Iisting 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 HDA'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 - Ms. Maureen O'Connell

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), pleasc 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,

Adul H. Milkan

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

K040433 510(k) Number (if known):

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)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

b. Mark A. Wilkerson

Restorative. Division of Gene and Neurological Devices

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