WAVELIGHT AURIGA

K051399 · Wavelight Laser Technologie AG · GEX · Jun 30, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051399
• Device Name: WAVELIGHT AURIGA
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

Device Story

AURIGA is a pulsed solid-state Holmium:YAG laser system (approx. 2080 nm wavelength). Device used by physicians in clinical/surgical settings for various specialties including urology, orthopedics, and ENT. System delivers laser energy to target tissue or stones via endoscopic or open surgical access. Laser energy facilitates stone fragmentation, tissue ablation, vaporization, excision, incision, and coagulation. Device operation is controlled by the surgeon to achieve specific therapeutic tissue effects. Benefits include minimally invasive surgical capabilities for stone management and soft tissue procedures.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Pulsed solid-state Holmium:YAG laser; wavelength approx. 2080 nm. System is a surgical laser instrument. No specific materials, connectivity, or software algorithm details provided.

Indications for Use

Indicated for patients requiring surgical intervention for stone fragmentation, tissue cutting, ablation, vaporization, excision, incision, or coagulation across specialties including Urology, Pulmonology, Arthroscopy, Gastroenterology, Gynecology, ENT, Lithotripsy, Orthopedics, Discectomy, and General Surgery. Applicable for open and endoscopic procedures.

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

• Dornier Medilas H
• Lumenis Versapulse Powersuite
• convergent Omnipulse 30
• Trimedyne Omnipulse

Submission Summary (Full Text)

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JUN 3 0 2005

K051399 1 of 2

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#### 510(k) Summary of Safety and Effectiveness - AURIGA Device

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

| Submitter: | WaveLight Laser Technologie, AG<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany |
|---------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Alexander Popp<br>WaveLight Laser Technologie, AG<br>Am Wolfsmantel 5<br>91058 Erlangen<br>Germany |
| Summary Preparation Date: | November 8, 2004 |
| Names: | |
| Device Name: | AURIGA |

Classification Name: Laser Instrument, Surgical Powered Product Code: GEX Panel: Dermatology and Plastic Surgerv

#### 3. Predicate Devices

2.

The AURIGA laser system is substantially equivalent to the Dornier Medilas H, Lumenis Versapulse Powersuite, convergent Omnipulse 30 or Trimedyne Omnipulse.

#### 4. Device Description

#### Device Description AURIGA :

The AURIGA is a pulsed solid-state Holmium YAG-Laser System with a wavelength of approx. 2080 nm. The system is suitable for interdisciplinary use in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures) , ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

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# S WaveLight®

510(k) Summary of Safety and Effectiveness – AURIGA Device

### 5. Indications for Use

The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

#### 6. Performance Data

not presented

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 3 0 2005

Wavelight Laser Technologie AG c/o Mr. Jeffrey D. Rongero 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709

Re: K051399 Trade/Device Name: Auriga Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 15, 2005 Received: June 17, 2005

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreaty 78 the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Ac. (1101) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, thance of the Act include requirements for annual registration, listing of general controls provisions of wastice, 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 If your device is classified (soo are roy als. Existing major regulations affecting your device can thay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTP issualles as our device complies with other requirements of the Act that I DA has made a actorimiations administered by other Federal agencies. You must of ally I coleral statutes und regarantents, including, but not limited to: registration and listing (21 Configure and the Free STequirements, only good manufacturing practice requirements as set CFN Fall 807), laocing (21 OF RT art 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jeffrey D. Rongero

This letter will allow you to begin marketing your device as described in your Section 510(k) This iction with anow yourse of substantial equivalence of your device to a legally prematicated predicated. The 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), please If you desire specific as not any and [phone]. Also, please note the regulation entitled, Connact the Office of Crain to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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S WaveLight®

510 (k) Indications for Use

Indications for Use

KOSI39 510(k) Number (if known): N/A AURIGA Device Name:

Indications for Use:

The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

Over-The-Counter Use Prescription Use × N/A AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page 1 of 1 (indication for use only

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