LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES

K971843 · Laserscope · GEX · Jul 23, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971843
• Device Name: LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
• Applicant: Laserscope
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laserscope VELA Erbium: YAG Laser System and Accessories are intended for the surgical incision. vaporization and congulation of soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage menus membranc, lymph vessels and nodes, organs and glands. DermatologyPlastic Surgery: Indications include, cpidcrmal nevi, teleagiestasia, soider veins, scinic chailitis, keloids, verrucee, skin togs, keratoses, sear revision, debulking banign tumors, decubitis ulcers and skin resurfacing. General Surgery: The Erbium: YAG lass is intended for the surgical incision, vaportuation and coagulation of soft tissue during any general surgery application where skin incision, tissue of external lumors and lesions, complete or partial resection of internal organs, tissue abletion and/or vessel coagulation may be indicated. Genitourinary: Indications include lesions of the external genitalia, welcon and anus, penis, scrown and urchire (includes condyloma acuminata, gian perined condyloma und verrucous carcinoma), valvar lesions, polyps and familial polyps of the colon. Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms. ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia. Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory. Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy. Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .

Device Story

Laserscope Erbium:YAG Laser System consists of a moveable console with power supplies, aiming laser, treatment laser, and cooling mechanism. User controls parameters via softouch keypad and LCD display. Aiming beam is coincident with Erbium:YAG beam, delivered through an articulating arm to a handpiece. Focusing adapters (1-8 mm spot sizes) attach to handpiece. Device used by clinicians for cutting, vaporizing, and coagulating soft tissue. Benefits include precise tissue ablation and coagulation across various surgical specialties.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Erbium:YAG laser system; 2.94 micron wavelength; articulating arm delivery; 1-8 mm spot size adapters; cooling mechanism for heat dissipation; conforms to 21 CFR 1040.10 and 1040.11.

Indications for Use

Indicated for surgical incision, vaporization, and coagulation of soft tissue (skin, subcutaneous, muscle, cartilage, mucous membrane, lymph, organs, glands) across dermatology, plastic surgery, general surgery, genitourinary, gynecology, ENT, oral/maxillofacial, ophthalmology, and podiatry specialties. Prescription use only.

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

• Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System

Submission Summary (Full Text)

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# K971843

JUL 23 1997

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE ERBIUM:YAG LASER SYSTEM AND ACCESSORIES

## REGULATORY AUTHORITY:

Safe Medical Devices Act of 1990, 21 CFR 807.92

#### COMPANY NAME/CONTACT:

Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: [phone] 943-1454 FAX:

### DEVICE TRADE NAME:

Laserscope Erbium:YAG Laser System and Accessories

#### DEVICE COMMON NAME:

Erbium:YAG Laser System

## DEVICE DESCRIPTION:

10

The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissipate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium:YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 8 mm.

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## SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2

#### DEVICE CLASSIFICATION:

Erbium:YAG Laser Systems and Accessories have not been specifically classified; however Nd:YAG, CO2, and Argon Surgical Lasers have been classified as Class II medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.

#### PERFORMANCE STANDARDS:

All Laserscope Erbium:YAG Surgical Laser Systems and Accessories conform with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.

#### INDICATION FOR USE STATEMENT:

The Laserscope Erbium: YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue.

All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

Clinical Applications:

Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry

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## SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3

## COMPARISON WITH PREDICATE DEVICE:

The Laserscope Erbium:YAG Laser System and Accessories is substantially equivalent to the Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System.

The risks and benefits for the Laserscope Erbium:YAG Laser System and Accessories are comparable to the predicate device when used for similar clinical applications.

Since the Laserscope Erbium:YAG Laser System and Accessories are substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa McGrath Sr. Regulatory Affairs Specialist Laserscope . . .. .. . . . . . . . . . . 3052 Orchard Drive San Jose, California 95134-2011

JUL 23 1997

Re: K971843

> Trade Name: Laserscope VELA Erbium: YAG Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: May 12, 1997 Received: May 14, 1997

Dear Ms. McGrath:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fo collafe

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT page I

843.

510(k) Number:

971843

Device Name: . . . . . . _ .. .

Laserscope Erbium: YAG Laser. System and Accessorics . . . . . . . . . . . . .

Indications for Use:

The Laserseope VELA Erbium: YAG Laser System and Accessories are intended for the surgical incision. vaporization and congulation of soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage menus membranc, lymph vessels and nodes, organs and glands.

DermatologyPlastic Surgery: Indications include, cpidcrmal nevi, teleagiestasia, soider veins, scinic chailitis, keloids, verrucee, skin togs, keratoses, sear revision, debulking banign tumors, decubitis ulcers and skin resurfacing.

General Surgery: The Erbium: YAG lass is intended for the surgical incision, vaportuation and coagulation of soft tissue during any general surgery application where skin incision, tissue of external lumors and lesions, complete or partial resection of internal organs, tissue abletion and/or vessel coagulation may be indicated.

Genitourinary: Indications include lesions of the external genitalia, welcon and anus, penis, scrown and urchire (includes condyloma acuminata, gian perined condyloma und verrucous carcinoma), valvar lesions, polyps and familial polyps of the colon.

Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms.

ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia.

Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory.

Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy.

Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .

Prescription Use
(Per 21 CFR 801.109)

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General Restorative Devices