GEMINI SURGICAL LASER SYSTEM & ACCESSORIES

K034011 · Laserscope · GEX · Mar 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K034011
• Device Name: GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
• Applicant: Laserscope
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laserscope Gemini™ Laser System & Accessories is indicated for: KTP/532 Applications: Dermatology: To treat moderate inflammatory Acne vulgaris. ND:YAG/1064 Applications: Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

Device Story

The Gemini Surgical Laser System is a powered laser instrument used in dermatology. It utilizes two laser wavelengths: KTP/532 for treating moderate inflammatory acne vulgaris and Nd:YAG/1064 for facial wrinkle treatment and permanent hair reduction in skin types I-VI. The system consists of an optical/laser resonator, electronics, operator interface, cooling subsystem, and various delivery devices/accessories. It operates by selectively targeting melanin in hair follicles for hair reduction. The device is intended for use by healthcare professionals in clinical settings. The physician operates the system to deliver laser energy to the target tissue, affecting clinical decision-making by providing a non-invasive therapeutic option for dermatological conditions. The system conforms to 21 CFR 1040.10 and 1040.11 performance standards.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, functional features, and indications for use compared to predicate devices.

Technological Characteristics

Powered laser surgical instrument. Dual-wavelength output: KTP/532 and Nd:YAG/1064. Includes optical/laser resonator, electronics, operator interface, and cooling subsystem. Conforms to 21 CFR 1040.10 and 1040.11 performance standards for medical laser systems.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris (KTP/532) and patients seeking treatment for facial wrinkles or permanent hair reduction in skin types I-VI (Nd:YAG/1064).

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

• Laserscope Lyra™ G Laser System and Accessories
• AURA i™ Surgical Laser System & Accessories
• Laserscope Lyra™ Laser System and Accessories

Submission Summary (Full Text)

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MAR 3 0 2004

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# 510(k) Summary Statement For the Gemini™ G Surgical Laser System & Accessories

### General Information

- A. Trade Name Gemini™ Series Surgical Laser System
- B. Common Name Laser Instrument, Surgical, Powered
- C. Establishment Registration Number

2937094

- D. Manufacturer's Identification
Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 [phone]-ext. 6795 [phone] FAX

Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs

- ட். Device Classification
The Gemini Series Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.

- F. Performance Standards
The Gemini Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

- G. Predicate Devices:
- Laserscope Lyra™ G Laser System and Accessories .
- AURA i™ Surgical Laser System & Accessories .
- Laserscope Lyra™ Laser System and Accessories .

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K034011
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#### Product Description: H.

The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems:

- The Optical and Laser resonator System .
- The Electronics and Electrical System ●
- Operator Interface .
- A variety of Delivery Devices and Accessories
- A Cooling Sub-system ●
- l. Indications For Use:

The Laserscope Gemini™ Laser System & Accessories is indicated for:

KTP/532 Applications:

Dermatology: To treat moderate inflamatory acne vulgaris:

# ND:YAG/1064 Applications:

Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

- J. Rationale for Substantial Equivalence
The Laserscope Gemini Surgical Laser System and Accessories share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to: the Laserscope Lyra G Surgical Laser System and Accessories; the Laserscope Aura "DL" Series Surgical Laser Systems (KTP/532, KTP/YAG™ and Nd: YAG/1064 Configurations);and, the Laserscope Lyra Laser System and Accessories. Details are provided in the Substantial Equivalence Section of this submission.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2004

Mr. Paul H. Hardiman Manager, Regulatory Affairs Laserscope 3070 Orchard Drive San Jose, California 95134

Re: K034011

Trade/Device Name: GEMINI™ Surgical Laser System & Accessories 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 22, 2003 Received: December 31, 2003

Dear Mr. Hardiman:

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 Revister.

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 rcquirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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]. 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.

Mark McMillan

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 STATEMENT

Page 1

510(k) Number:

## K034011

GEMINI™ SURGICAL LASER SYSTEM & ACCESSORIES Device Name:

INTENDED USE:

The Laserscope Gemini™ Laser System & Accessories is indicated for:

#### KTP/532 Applications:

Dermatology: To treat moderate inflammatory Acne vulgaris.

#### ND:YAG/1064 Applications:

Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: or (per 21 CFR 801.109)

Over The-Counter-Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANJOTHER PAGE)

/ Mark A. Millman

Restorative, and Neurologic

K034011
Number