EQUILASE SYSTEM

K022464 · Equilasers, Inc. · GEX · Nov 21, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022464
• Device Name: EQUILASE SYSTEM
• Applicant: Equilasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 21, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Equilase system, used together with a FDA cleared fiber optic delivery system, is intended for general surgical incision/excision, vaporization, ablation and coagulation of soft tissues. All soft tissues such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, are included.

Device Story

Equilase System is a surgical Nd:YAG laser; generates 1064 nm laser radiation via flashlamp-excited Nd:YAG rod. System includes laser head, power conditioner, cooling system, microprocessor controller, membrane keypad, and footswitch. Aiming light provided by 640-660 nm laser diode. Used in general surgery, plastic surgery, and dermatology; operated by clinicians. Laser energy delivered via optical fiber to target soft tissue for incision, excision, vaporization, ablation, or coagulation. Microprocessor regulates system functions and monitors sensors; user interface displays parameters. Benefits include precise soft tissue management during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nd:YAG laser; 1064 nm wavelength; pulsed mode; multi-mode spatial profile. Closed-loop air-to-water heat exchanger cooling. 640-660 nm laser diode aiming light. Optical fiber beam delivery (0.22 NA). Microprocessor-based controller. Membrane switch user interface with LCD display. Footswitch activation. Audible tone during firing.

Indications for Use

Indicated for general surgical incision, excision, vaporization, ablation, and coagulation of soft tissues, including skin, cutaneous/subcutaneous tissue, muscle, cartilage, mucous membranes, lymph vessels/nodes, organs, and glands. For 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

• Laserscope's Lyra Series Surgical Laser System and Accessories (K990903)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for a company called "EQUI LASERS INCORPORATED". The word "EQUI" is in a bold, sans-serif font and is placed inside a black circle. The words "LASERS INCORPORATED" are in a serif font and are placed to the right of the black circle. The word "LASERS" is larger than the word "INCORPORATED".

NOV 21 2002

Laser System Design, Application,

K022464

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## Premarket Notification [510(k)] Summary

July 22, 2002 Revised October 25, 2002

Trade Name: Equilase System

Common Name: Surgical Nd:YAG Laser

| Classification Name: Powered Surgical Laser Instrument, GEX |
|-------------------------------------------------------------|
| 21 CFR section 878.4810, Class II |

| Manufacturer's Name: | Equilasers, Inc. |
|----------------------|-------------------------------------------------------|
| Address: | 3350 Scott Boulevard, Unit 5<br>Santa Clara, CA 95054 |

| Corresponding Official: | Richard C. Sam, Ph.D. |
|-------------------------|-----------------------|
| Title: | President and CEO |

Telephone: [phone] Fax: [phone]

Predicate: Laserscope's Lyra Series Surqical Laser System and Accessories. K990903.

Device Description: The Equilase System consists of 6 major subsystems:

1. A laser head, where laser radiation is generated from flashlamp excitement of a laser rod in a laser resonator, and the output is focused to a point. The laser head also houses a visible laser diode (VLD). Its beam is combined with the main laser beam as a aiming light.

2. A power conditioner where the input AC power is converted to electrical energy stored in capacitors for discharge into the flashlamp.

3. A cooling system to remove excess heat from the pump chamber, which is located inside the laser head.

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4. A microprocessor based controller that regulates the functions of the laser system, checks status of various sensors.

5. A membrane switch keypad for user interface and provides laser parameters readout.

6. A footswitch for activating laser action.

Intended Use: The Equilase surgical laser system is intended for use in general and plastic surgery, and dermatology.

Technological Characteristics:

| Characteristics | Lyra Surgical Laser | Equilase System |
|-------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Active Medium | Nd:YAG laser rod | Nd:YAG laser rod |
| Wavelength | 1064 nm | 1064 nm |
| Temporal Mode | Pulsed | Pulsed |
| Exposure Control | Adjustable Exposure Time | Adjustable Exposure Time |
| Spatial Mode | Multi-mode | Multi-mode |
| Cooling | Closed loop, internal air-to-<br>water heat exchanger | Closed loop, internal air-to-<br>water heat exchanger |
| Aiming Light | 630-680 nm laser diode | 640-660 nm laser diode |
| Controller | Micro-processor based<br>controller | Micro-processor based<br>controller |
| User Interface | LCD display | LCD display |
| Beam Delivery | Optical fiber, 0.22 NA | Optical fiber, 0.22 NA |
| Operator Firing<br>Control | Footswitch or hand switch | Footswitch |
| Audible Tone during<br>laser firing | Yes | Yes |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 1 2002

Equilasers, Inc. Richard C. Sam. Ph.D. President and CEO 3350 Scott Boulevard, Unit 5 Santa Clara, California 95054

Re: K022464

Trade/Device Name: Equilase System Regulation Number: 878.4810 Regulation Name: Powered surgical laser instrument Regulatory Class: Class II Product Code: GEX Dated: October 25, 2002 Received: October 28, 2002

Dear Dr. Sam:

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

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Page 2 – Dr. Richard C. Sam

quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 vou 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). 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

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

Enclosure

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## Tab 3

# Indications For Use

510(k) Number: Ko224G4

Device Name: Equilase System

#### Indications for Use:

The Equilase system, used together with a FDA cleared fiber optic delivery system, is intended for general surgical incision/excision, vaporization, ablation and coagulation of soft tissues. All soft tissues such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, are included.

#### (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musician C. Provost

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number K022464

Prescription Use
(per 21 CFR 801.109)
OR

Over-The-Counter Use__