SHARPLAN CO2 SURGICAL LASER SYSTEM

K971743 · Sharplan Lasers, Inc. · GEX · Jul 18, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971743
• Device Name: SHARPLAN CO2 SURGICAL LASER SYSTEM
• Applicant: Sharplan Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.

Device Story

Sharplan 15F CO2 Laser System functions as a heat source for activating tooth bleaching materials. Device emits a laser beam at 10.6 um wavelength with power output up to 15 watts; operates in continuous or pulse wave modes. Used by clinicians in dental settings. Output is a thermal laser beam applied to bleaching agents to accelerate chemical activation. Benefits include controlled thermal energy delivery for dental whitening procedures.

Clinical Evidence

No clinical data presented.

Technological Characteristics

CO2 laser system; 10.6 um wavelength; up to 15 watts power output; continuous or pulse wave operation modes. Class II device.

Indications for Use

Indicated for use as a heat source to activate tooth bleaching materials in a clinical setting.

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

• Sharplan 15F CO2 Laser (K950725)
• ILT CO2 Laser System (K954460)

Submission Summary (Full Text)

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K971743

## 510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. 15F CO2 Laser System an Expanded Indication for Use

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 15F CO2 Laser System for the intended use as a heat to activate tooth bleaching materials is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan 15F CO2 Laser and the Ion Laser Technology (ILT) CO2 Laser System.

- 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance April 30, 1997
- Model: Sharplan Model 15F CO2 Laser 2.
- Predicate Devices: The Sharplan 15 F CO2 Laser (K950725) and the ILT CO2 Laser 3. System (K954460).
- Description: The Sharplan Model 15F CO2 Surgical Laser is a medical device which 4 . capable of being used as a heat source for activating tooth bleaching materials. It emits a treatment laser beam at a wavelength of 10.6 um up to 15 watts in either continuous or pulse wave modes of operation.
- 5 . The Sharplan Model 15F (for this indication) is substantially equivalent to the following devices: The Sharplan 15F CO2 Laser which is intended for use in ENT and soft tissue dentistry and the ILT Surgical Laser which is intended for use as a heat source to activate tooth bleaching materials, as well as soft tissue incision and ablation in ENT, and soft tissue dentistry.

No new intended use for a CO2 Laser was sought in this premarket notification. Therefore, no clinical data was presented.

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## 510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. 15F CO2 Laser System an Expanded Indication for Use (continued)

- From a design and clinical perspective, the predicate and candidate laser devices, are of the 6. same technology (one device is identical), 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. Furthermore, this expanded indication does not raise any concerns regarding the safety or effectiveness of the Sharplan Lasers, Inc. 1 5F CO2 Laser System for use as a heat source to activate tooth bleaching materials.
- 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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## 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 arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 18 1997

K971743 Re:

Trade Name: Sharplan Model 15F CO, Laser Regulatory Class: II Product Code: GEX Dated: May 9, 1997 Received: May 12, 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 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,

- 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):

Device Name: Sharplan 15F CO2 Laser System_

Indications For Use:

The Sharplan 15F CO2 Laser System is intended for use as a heat source to activate tooth bleaching materials.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971743

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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