SHARPLAN EPITOUCH RUBY LASER SYSTEM

K972099 · Sharplan Lasers, Inc. · GEX · Aug 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972099
• Device Name: SHARPLAN EPITOUCH RUBY LASER SYSTEM
• Applicant: Sharplan Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.

Device Story

Sharplan EpiTouch Ruby Laser System is a surgical laser providing pulsed 694.3 nm wavelength energy in free-running mode. Device utilizes an optical fiber beam delivery system. Physician operates device via foot switch while observing a 633 nm HeNe aiming beam. Used in dermatology clinics for removal of unwanted dark body hair. Output is laser energy delivered to target tissue; clinical decision-making relies on physician observation and control of the treatment beam. Benefits include non-invasive hair removal.

Clinical Evidence

No clinical data presented.

Technological Characteristics

Pulsed ruby laser system; 694.3 nm treatment wavelength; 633 nm HeNe aiming beam; optical fiber beam delivery system; foot switch activation; Class II device.

Indications for Use

Indicated for dermatology patients requiring removal of unwanted dark body hair.

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

• SLS Chromos 694 QD Ruby Laser System (K962109)

Submission Summary (Full Text)

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KG 2077

## AUG 27 1997

## 510(k) Summary of Safety and Effectivemess Sharplan Lasers, Inc. Modified Ruby Laser System

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of Sharplan Modified Ruby Laser System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device which is the SLS Chromos 694 QD Ruby Laser System.

- 1 . Sharplan Lasers, Inc. l Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance June 3, 1997
- 2. Model: Sharplan Model 5000 (Modified) EpiTouch Ruby Laser System
- Predicate Device: The SLS Chromos 694 QD Ruby Laser System (K962109) 3.
- Description: The Sharplan Ruby Laser System is a surgical laser which is capable of 4 . providing pulsed laser energy of a 694.3 nm wavelength in the free running mode through an optical fiber beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.
- 5 . The Sharplan Ruby Laser System (modified, with its fiber delivery system ) is intended for use in dermatology for the removal of unwanted dark body hair. No new indications were sought in this premarket notification. Therefore, no clinical data was presented.

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## Slouk) Summary of Safety and Effectivemess Sharplan Lasers, Inc. Modified Ruby Laser System (continued)

- For the purpose of this 510(k) notification, the predicate and candidate laser devices, are 6. of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Therefore, the modifications made to the Sharplan Ruby Laser System should not raise any concerns regarding its overall safety or effectiveness.
- This information was prepared for the sole purpose of compliance with the Advisory: Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.

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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 stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1997

Mr. George J. Hattub Director of Regulatory Affairs/Quality Assurance, CQE Sharplan Lasers, Inc.. . . . . . . . . . . . . . . . 1 Pearl Court Allendale, New Jersey 07401

Re: K972099 Trade Name: Sharplan EpiTouch Ruby Laser System Regulatory Class: II Product Code: GEX Dated: June 3. 1997 Received: June 4, 1997

Dear Mr. Hattub:

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 (OS) 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 inay 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

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Page 2 - Mr. George J. Hattub

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

Sincerely yours,

[signature]

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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510(k) Number (If known): K972099

Device Name: Sharplan Ruby Laser System

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Indications For Use:

The Sharplan Ruby Laser System, with its fiber delivery system, is intended for use in dermatology for the removal of unwanted body hair.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Acolla

(Divisio of General Restorative Devices Division 2972099 510(k) Num

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ____

(Optional Format 1-2-96)