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.
In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.

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.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the WaveLight SINON laser system. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that no performance data is presented. Therefore, I cannot extract the requested information to describe acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:
"6. Performance Data
None presented."

This means that the document does not contain:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or data provenance.
Information on experts or ground truth establishment.
Adjudication methods.
MRMC comparative effectiveness study results.
Standalone performance data.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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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, AGAm Wolfsmantel 591058 ErlangenGermany
Contact Person:	Alexander PoppAm Wolfsmantel 591058 ErlangenGermanyTelephone: +49 (0)9131-6186-121Fax: +49 (0)9131-6186-202
Summary Preparation Date:	December 16, 2004
2. Names
Device Name:	SINON
Classification Name:	Laser Instrument, Surgical PoweredProduct Code: GEXPanel: 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

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.
1. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
1. 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 (800) 638-2041 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®

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.
1. 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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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.