SHARPLAN ERBIUM: YAG LASER (4020)

K971648 · Sharplan Lasers, Inc. · GEX · Jul 23, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971648
• Device Name: SHARPLAN ERBIUM: YAG LASER (4020)
• Applicant: Sharplan Lasers, Inc.
• 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 Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for incision/excision, ablation, vaporization, and/or coagulation of soft-tissue in-Plastion-Surgery/Dermatology.

Device Story

Sharplan Model 4020 Erbium:YAG Surgical Laser is a medical laser system emitting an invisible pulsed treatment beam at 2.94 µm wavelength, guided by a visible aiming beam. It operates in continuous or timed exposure modes. Used by physicians in plastic surgery and dermatology settings for soft tissue management (incision, excision, ablation, vaporization, coagulation). The device provides a surgical tool for tissue interaction; clinical decision-making remains with the physician based on visual assessment of the surgical site. Benefits include precise soft tissue removal and coagulation capabilities.

Clinical Evidence

No clinical data was presented. Substantial equivalence is based on design and technological similarities to predicate devices.

Technological Characteristics

Erbium:YAG laser system; 2.94 µm wavelength; invisible pulsed treatment beam with visible aiming beam; continuous or timed exposure modes.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and/or coagulation of soft tissue in plastic surgery and dermatology.

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

• SEO Medical Model 2940 Erbium YAG Laser (K954013)
• Candela (Fotona) SkinLight Er:YAG Laser (K962902)
• Con Bio Erbium/2.94 Laser (K961748)
• ESC Derma 20 Erbium: YAG Laser
• Asculap MCL 29 Erbium: YAG Laser (K964128)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Sharplan Lasers, Inc. The logo consists of a circular graphic on the left, with three inward-pointing arrows forming a pie chart-like shape. To the right of the graphic is the word "SHARPLAN" in large, bold, sans-serif font, and below that, in a smaller font, is the text "LASERS, INC."

- 2 3 1997

510(k) Summary of Safety and Effectivemess Sharplan Lasers, Imc. Model 4020 Erbium YAG 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 Model 4020 Erbium YAG Laser System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: SEO Medical Model 2940 Erbium YAG Laser, Candela (Fotona) SkinLight Er: Y AG Laser, Con Bio Erbium/2.94 Laser, ESC Derma 20 Erbium: Y AG Laser, and Asculap MCL 29 Erbium: Y AG Laser.

- 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance May 2, 1997
- Model: Sharplan Model 4020 Erbium YAG Laser 2 .
- Predicate Devices: SEO Medical Model 2940 Erbium Y AG Laser (K954013), Candela 3 . (Fotona) SkinLight Er:YAG Laser (K962902), Con Bio Erbium/2.94 Laser (K961748), ESC Derma 20 Erbium: Y AG Laser (cleared April, 1997), and Asculap MCL 29 Erbium: YAG Laser (K964128).
- 4 . Description: The Sharplan Model 4020 Erbium YAG Surgical Laser is a medical device which capable of emitting an invisible pulsed treatment laser beam at a wavelength of 2.94 u under the guidance of an visible aiming beam. This laser can be utilized in either the continuous or timed exposure modes of operation
- 5 . The Sharplan Model 4020 Erbium YAG Surgical Laser is intended for incision/excision, ablation, vaporization, and/or coagulation of soft tissue in Plastic Surgery/Dermatology. No new indications were sought in this premarket notification and no clinical data was presented.

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## 510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. Model 4020 Erbium YAG Laser System (continued)

- From both a design and clinical perspective, 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 Sharplan Model 4020 Erbium Y AG Surgical Laser should not raise any concerns regarding its overall safety or effectiveness.
- Advisory: This information was prepared for the sole purpose of compliance with the 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 seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with its wings spread, and three human figures in profile below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the top of the seal.

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 2 3 1997

Re: K971648

Trade Name: Sharplan Model 4020 Erbium YAG Laser Regulatory Class: II Product Code: GEX Dated: May 2, 1997 Received: May 5, 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 (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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Page 2 - Mr. George J. Hattub

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): 上午7 1648

Device Name: Sharplan Model 4020 Erbium:YAG Laser System_

Indications For Use:

The Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for incision/excision, ablation, vaporization, and/or coagulation of soft-tissue in-Plastion-Surgery/Dermatology.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General Restorative Devices K971648
510(k) Number

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use - - - -

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