CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM

K021946 · Cell Robotics, Inc. · GEX · Sep 11, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021946
• Device Name: CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
• Applicant: Cell Robotics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.

Device Story

The Cell Robotics Ultra-Light Laser System is an Erbium:YAG laser emitting at 2940nm. The system comprises a cabinet housing the power supply, cooling system, and electronics, connected via umbilical cables to a handpiece containing the laser source. It is used by clinicians in dermatology, plastic surgery, oral surgery, and ophthalmology to perform soft tissue procedures including coagulation, vaporization, ablation, and cutting. The device operates as a surgical tool for tissue modification.

Clinical Evidence

No clinical data or nonclinical performance data required.

Technological Characteristics

Erbium:YAG laser; 2940nm wavelength; cabinet-based power supply and cooling system; handpiece-integrated laser source.

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.

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

• Schwartz Electro-Optics TriLase2940 (K954013)
• Cell Robotics Er: YAG Laser System (K970461)
• Asceplion-Meditec Dermastar Er: Y AG Laser System (K014057)

Submission Summary (Full Text)

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Attachment I

K021946

## 510(K) Summary Cell Robotics Ultra-Light Laser System

This 510(K) Summary of safety and effectiveness for the Cell Robotics Ultra-Light Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant: | Cell Robotics, Inc. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2715 Broadbent Parkway NE<br>Albuquerque, NM 87107 |
| Contact Person: | Glen Goff, Manager of Regulatory Affairs |
| Telephone:<br>Telefax: | [phone] Ext. 124<br>[phone] |
| Preparation Date: | 05/21/02 |
| Device Trade Name: | Cell Robotics Ultra-Light Laser System |
| Common Name: | Erbium:YAG laser device |
| Classification Name: | Instrument, Powered, Laser<br>79-GEX<br>21 CFR 878-48 |
| Legally Marketed Predicate<br>Device: | Schwartz Electro-Optics TriLase2940, K# 954013<br>Cell Robotics Er: YAG Laser System, K# 970461<br>Asceplion-Meditec Dermastar Er: Y AG Laser System,<br>K#014057 |
| Description of the Device | The Cell Robotics Ultra-Light Laser System is an Er: Y AG<br>laser producing emission at a wavelength of 2940nm. The<br>laser consists of two interconnected sections: The cabinet<br>which houses the power supply, the cooling system and<br>the electronics, and; the umbilical cables and the<br>handpiece, which houses the laser. |
| Intended Use of the Device | The Cell Robotics, Inc. Ultra-Light Laser System is<br>intended for coagulation, vaporization, ablation, or cutting<br>of soft tissue (skin) in dermatology, plastic surgery<br>(including aesthetic surgery), oral surgery, and<br>ophthamology. |
| Nonclinical Performance<br>Data: | None Required |
| Clinical Performance Data: | None Required |
| Conclusion: | The Cell Robotics Ultra-Light Laser System is<br>substantially equivalent to other existing legally marketed<br>laser systems currently in commercial distribution. |
| Additional Information: | None requested at this time |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that suggests forward movement or progress.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cell Robotics, Inc. Glen Goff Manager of Regulatory Affairs 2715 Broadbent Parkway, NE Albuquerque, New Mexico 87107

Re: K021946

Trade/Device Name: Cell Robotics Ultra-Light Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: June 12, 2002 Received: June 13, 2002

Dear Mr. Goff:

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. Ilsting 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. Glen Goff

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 and additionally 21 CFR Part 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 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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## INDICATION FOR USE STATEMENT

K 621946 510(k) Number: .

Device Name: Cell Robotics Ultra-Light Laser System

Indications for Use:

The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styplurth

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

510(k) Number K021946

Prescription Use
(per 21 CFR 801.109)

OR

Over-the-Counter Use