MEDLITE Q-SWITHCED LASER

K022709 · Continuum Electro-Optics, Inc. · GEX · Feb 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K022709
• Device Name: MEDLITE Q-SWITHCED LASER
• Applicant: Continuum Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation and hemostasis. The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.

Device Story

Medlite Q-Switched Laser is a powered surgical laser system using Nd:YAG technology. It delivers laser energy via a handpiece connected to an articulated arm. The device is operated by a clinician in a clinical setting. It functions by emitting light energy to perform coagulation, hemostasis, and skin resurfacing for acne scars and wrinkles. The system includes microprocessor control to manage pulse parameters, including pulse rates (1, 2, 5, 10 Hz, or single shot) and pulse durations (less than 20 nsec). The output allows the physician to target specific tissue for therapeutic effect, aiding in dermatologic and surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance comparisons to legally marketed predicate devices.

Technological Characteristics

Nd:YAG laser medium; Q-switched pulse method; 1064 nm and 532 nm wavelengths; 30 Watts max power; articulated arm beam delivery; multimode beam quality; microprocessor-controlled; 110/120V or 220/240V power supply; pulse duration <20 nsec; pulse rates 1, 2, 5, 10 Hz and single shot.

Indications for Use

Indicated for patients requiring dermatologic or general surgical procedures for coagulation, hemostasis, or laser skin resurfacing for the treatment of acne scars and wrinkles.

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

• Thermolase SoftLight Laser (K971207)
• Medlite Q-Switched Laser (K983054)

Submission Summary (Full Text)

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022709

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| 1. | Device Name: | | |
|----|----------------------|--------------------------------------|--------------|
| | Trade Name: | Medlite Q-Switched Laser | |
| | Common Names: | Surgical Laser | |
| | Classification Name: | Instrument, Surgical, Powered, Laser | FEB 2 0 2003 |

Establishment Name & Registration Number: 2. Name: Hova-ConBio, Inc. Number: Pending

#### 3. Classification:

Title 21. Code of Federal Regulations.

Sec. 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 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 Sec. 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

ProCode: 79GEX

#### 4. Guidance Documents. Performance Standards and Special Controls:

At the present time, the following guidance documents are in effect for this device:

Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

Compliance Guide for Laser Products (FDA 86-8260)

Laser Products-Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50)

FDA mandated performance standards for this device exist and are specified under 21 CFR, \$1010. These standards, including OSR required as required by regulation. Voluntary standards such as UL, in-house Standard Operating Procedures and vendor qualification procedures are in place and utilized in the production of the Medlite O-Switched Laser.

#### Equivalent Device(s): 5.

The Medlite Q-Switched Laser claims substantial equivalence to the Thermolase SoftLight Laser, K971207 and the Medite () Switched Laser previously cleared via K983054. A feature comparison table is included on the following page for visual comparison of equivalence factors.

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### Applicant/Sponsor Name / Address: 6.

Hoya-ConBio, Inc. 47733 Fremont Blvd. Fremont, CA 94538 510.445.4500 - 510.445.4550

#### 7. Company Contact:

Mr. Dan Romitelli Hoya-ConBio, Inc. 47733 Fremont Blvd. Fremont, CA 94538 510.445.4500 - 510.445.4550

#### Submission Correspondent: જે.

David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 fax david(@fda-help.com

#### 9. Manufacturing Facility:

Hoya-ConBio, Inc. 47733 Fremont Blvd. Fremont, CA 94538 510.445.4500 - 510.445.4550

#### Description of the Device and Indications for Use: 10.

| Feature | Medlite Q-Switched Laser | Medlite Q-Switched Laser, K014234 | ThermoLase Laser, K971207 | SoftLight SE? |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------|---------------|
| Indications For Use: | The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for ecoagulation and hemostasis.<br><br>The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles. | Identical<br><br>No | Identical | Yes |
| Laser Medium: | Nd:YAG | Nd:YAG | Nd:YAG | Yes |
| Pulse Method: | Q-Switched | Q-Switched | Q-Switched | Yes |
| Max Power: | 30 Watts | 30 Watts | 30 Watts | Yes |
| Wavelength: | 1064 & 532 | 1064 &532 | 1064 | Yes |
| Power Supply: | 110/120 VAC - 50/60 Hz<br>220/240 VAC - 50/60 Hz | 110/120 VAC - 50/60 Hz | 117/230 VAC - 50/60 Hz | Yes |
| Pulse Rate: | 1, 2, 5, 10, Single Shot | 1, 2, 5, 10, Single Shot | 1, 2, 5, 10, Single Shot | Yes |
| Pulse Duration (nsec): | Less than 20 | Less than 20 | 6-20 | Yes |
| Beam Delivery: | Handpiece using articulated arm | Handpiece using articulated arm | Handpiece using articulated arm | Yes |
| Beam Quality: | Multimode | Multimode | Multimode | Yes |
| Microprocessor Control: | Yes | Yes | Yes | Yes |
| Manufacturer: | Hoya-ConBio, Inc. | Continuum Electro-Optics, Inc. | ThermoLase Corporation | Yes |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 0 2003

Hoya-ConBio, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Pleasant Hill, California 94523-3389

Re: K022709

Trade/Device Name: Medlite O-Switched Laser 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: December 15, 2002 Received: December 31, 2002

Dear Mr. Schlerf:

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 - Mr. David W. Schlerf

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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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 vours.

Muriam C. Provost

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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## 510(k) NUMBER: K022709

DEVICE NAME : Medlite Q-Switched Laser

INDICATIONS FOR USE:

The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation and hemostasis.

The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General. Restorative and Neurologi . . . evices

OR

810(k) Number ________________________________________________________________________________________________________________________________________________________________

**Prescription Use** /
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional format 1-2-96)

MedliteResponse2.doc