PHACOLASE ER: YAG LASER

K991993 · Aesculap-Meditec GmbH · GEX · Nov 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991993
• Device Name: PHACOLASE ER: YAG LASER
• Applicant: Aesculap-Meditec GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, excision, vaporization, and ablation of soft tissue in ophthalmology: Anterior capsulotomy Soft tissue surrounding the orbit of the eye Aesculap-Meditec proposes that the Phacolase™ Er:YAG laser be labeled; "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."

Device Story

Phacolase™ Er:YAG laser emits coherent light at 2.94 microns for ophthalmic soft tissue procedures. Device performs cutting, incision, excision, vaporization, and ablation. Used in clinical settings by ophthalmologists. Output is laser energy delivered to target tissue; enables precise tissue removal during anterior capsulotomy or orbital soft tissue surgery. Benefits include controlled tissue interaction compared to traditional methods. Clinical decision-making relies on physician assessment of surgical site and laser application.

Clinical Evidence

Preclinical and clinical testing submitted to support claims for incision and fragmentation of cataractous lenses during cataract surgery.

Technological Characteristics

Er:YAG laser; 2.94 micron wavelength; coherent light emission. Class II laser surgical instrument (21 CFR 878.4810).

Indications for Use

Indicated for cutting, incision, excision, vaporization, and ablation of soft tissue in ophthalmology, specifically anterior capsulotomy and soft tissue surrounding the orbit of the eye. Restricted to prescription use by licensed professionals.

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.

Submission Summary (Full Text)

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NOV 1 7 1999

1 991993

APPENDIX F Rev. Oct. 1999

## 510(k) SUMMARY AESCULAP-MEDITEC PHACOLASE™ ER:YAG LASER

This 510(k) summary of safety and effectiveness for the Phacolase™ Er:Y AG laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant: Aesculap-Meditec

Address: 2525 McGaw Avenue Irvine, CA 92623-9791

Manufacturer: Aesculap-Meditec GmbH Prussingstrasse 41 D-07745 Jena Germany (011) +49/3641/653223 (011) +49/3641/652121

Contact Person: Mr. William T. Kelley

Telephone: [phone] (Fax)

Preparation Date: November 1999 (of the Summary)

Phacolase™ Er: YAG laser Device Name:

Common Name: Er:YAG laser

Classification Laser surgical instrument for use in general and plastic surgery and in Name: dermatology (see: 21 CFR 878.4810). Product Code: GEX Panel: 79

The Aesculap-Meditec Phacolase™ Er: YAG laser emits a beam of coherent Description: light at 2.94 microns.

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- The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, Indications: excision, vaporization, and ablation of soft tissue in ophthalmology:
Anterior capsulotomy Soft tissue surrounding the orbit of the eye

Aesculap-Meditec proposes that the Phacolase™ Er:YAG laser be labeled; "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."

- The Aesculap-Meditec Phacolase™ Er:YAG laser was compared to predicate Comparisons lasers with the cited indications.
- Performance Data: The results of a preciinical and clinical testing were submitted in support of the claim for incision and fragmentation of cataractous lenses during cataract surgery.
- CONCLUSION: Based on the preclinical and clinical testing and on comparisons of specifications and other descriptive information the Aesculap-Meditec Phacolase™ Er: YAG laser is substantially equivalent for its claimed indications for use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 1999

Mr. William T. Kelley General Manager Aesculap-Meditec 2525 McGaw Avenue Irvine, California 92623-9791

K991993 Re: Trade Name: Phacolase™ Er:YAG Regulatory Class: II Product Code: GEX Dated: September 13, 1999 Received: September 21, 1999

Dear Mr. Kelley:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. William T. Kelley

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,

Stypt Rhodes

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX B2 Rev. Nov. 1999

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known): # # 99 / 2 9 3

Device Name: Aesculap-Meditec Phacolase™ Er:YAG laser

Indications For Use Statement:

The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, excision, vaporization, and ablation of soft tissue in ophthalmology:

Anterior capsulotomy Soft tissue surrounding the orbit of the eye

Aesculap-Meditec proposes that the Phacolase™ Er.YAG laser be labeled: "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."

This labeling will be included in the final printing of the manuals and on literature relating to the device.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The

that Rivels

(Division Sign-Off) Division of General Restorative Devices K991993 Sluk, Number

Over-The-Counter Use