Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES

K043173 · Lumenis, Ltd. · GEX · Jan 31, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043173
• Device Name: Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores. The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for: - Removal of dark tattoos - Treatment of pigmented lesions

Device Story

Q-switched Nd:YAG laser treatment head; upgrade for Lumenis Quantum series systems (Quantum HR, SR, DL). Device delivers 1064 nm pulsed laser energy via handpiece connected to console. Operates via selective photothermolysis and photo-acoustic effects on target chromophores. Used by physicians in plastic surgery and dermatology clinics. System includes console with control electronics, display panel, and handpiece with optics, trigger circuit, and cooling. Healthcare provider uses device to target lesions or tattoos; energy absorption leads to clinical treatment effect. Benefits include removal of dark tattoos and treatment of pigmented lesions.

Clinical Evidence

Clinical Evaluation Report provided to demonstrate safety and effectiveness for the claimed indications. No specific study metrics (e.g., sensitivity, specificity) or sample sizes reported in the summary.

Technological Characteristics

Pulsed laser operating at 1064 nm. Handheld treatment head includes optics, trigger circuit, safety components, and cooling circuit. Connects to Quantum console via umbilical cable. Energy source: Nd:YAG laser. Class II device.

Indications for Use

Indicated for removal of dark tattoos and treatment of pigmented lesions in patients requiring plastic surgery or dermatology procedures.

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

• MedLite C3 Q-switched Nd: YAG laser (K011677)
• Light-Age O-Clear laser (K033259)
• Q-YAG 5 laser (K003460)
• Q-YAG 5 laser (K023967)

Reference Devices

• Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K020839)
• Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K030527)
• Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K024093)
• Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K030342)

Submission Summary (Full Text)

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### Attachment 17 K043173 510(k) Summary for the Q-switched Nd: YAG Laser Treatment Head for the Lumenis Quantum Series

#### I. General Information

| Submitter: | Lumenis, Inc.<br>2400 Condensa Street<br>Santa Clara, CA 95051 |
|---------------------------|----------------------------------------------------------------|
| Contact Person: | Martha Murari, Ph.D.<br>Senior Regulatory Affairs Associate |
| | Connie Hoy<br>Global Director RA / QA |
| Summary Preparation Date: | November 15, 2004 |

#### II. Names

Device Names:

Q-switched Nd:YAG Laser Treatment Head for the Quantum Series

Laser Powered Surgical Instrument (and Accessories) Primary Classification Name:

#### Predicate Devices III.

- Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K020839, . K030527, K024093, K030342) marketed by Lumenis.
- MedLite C3- Q Switched Nd: YAG laser (K011677) marketed by Hoya ConBio (formerly ● Continuum Electro-Optics)
- Light-Age O-Clear laser (K033259) marketed by Light Age Inc. .
- Q-YAG 5 laser (formerly Clear Light)(K003460, K023967) marketed by Palomar ● Medical Technologies Inc.

#### IV. Product Description

The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:

- A system console (including software and control electronics, key-operated power control . switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
- . A control and display panel;
- One or more delivery handpiece(s), the Treatment Heads. .

The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.

The Q-switched Nd: Y AG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.

510(k) Submission: Q-switched Nd: YAG Laser Treatment Head for the Quantum Series Attachment 17 - Page 1

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#### V. Indications for Use

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:

- Removal of dark tattoos �
- Treatment of pigmented lesions .

#### Rationale for Substantial Equivalence VI.

The Q-switched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use as the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460), in that the 1064 nm wavelength is indicated for:

- Removal of dark tattoos �
- Treatment of pigmented lesions .

The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460).

Therefore, the Q-switched Nd:YAG Laser Treatment Head for the Quantum series is substantially equivalent to the predicate devices.

#### Safety and Effectiveness Information VII.

The Q-switched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices. A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use. The Q-switched Nd: Y AG Laser Treatment Head for the Quantum series does not raise new questions of safety and efficacy.

## VIII. Conclusion

Based on the foregoing, the Q-switched Nd: Y AG Laser Treatment Head for the Quantum series was found to be substantially equivalent to the predicate MedLite C2 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Lumenis, Ltd. c/o Martha Murari, Ph.D. Senior Regulatory Affairs Associate Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051

Re: K043173

Trade/Device Name: Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series (Quantum HR, Quantum SR and Quantum DL) 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: November 15, 2004 Received: November 16, 2004

Dear Dr. Murari:

We have reviewed your Section 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, 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 (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 FDA'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 – Martha Murari, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ maing of substantial equivalence of your device to a legally premative hotification. The PDF Interessification 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 advision 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 other general information on Jour Copsumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Cclia 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

510(k) Number (if known): < 043173

Device Name: _Q-switched Nd: YAG Laser Treatment Head for the Lumenis Quantum series [Quantum HR, Quantum SR, and Quantum DL]

Indications for Use:

The Q-switched Nd: YAG Laser Treatment Head for the Quantum series in indicated for:

- Removal of dark tattoos .
- Treatment of pigmented lesions .

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (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)

miriam C. Provost (Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

**510(k) Number** K043173

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Lumenis 510(k) Submission: Q-switched Nd:YAG Laser Treatment Head for the Quantum Series Attachment 2 - Page 1