OCULASE MD

K052354 · Biolase Technology, Inc. · GEX · Jul 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052354
• Device Name: OCULASE MD
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oculase MD may be indicated for general ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

Device Story

Oculase MD is an Er,Cr:YSGG laser system for ophthalmic soft tissue surgery. Device delivers laser energy via flexible fiber optic and handpiece to target tissue; red aiming beam pinpoints treatment area. System incorporates sterile water spray during laser delivery to tissue site. Handpiece is rotatable and detachable; tip serves as optical power conduit. Operated by clinicians in surgical settings. Laser power output is adjustable by user. Device facilitates incision, excision, vaporization, and coagulation of ocular and surrounding tissues.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Er,Cr:YSGG (Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet) laser system. Features flexible fiber optic delivery, rotatable/detachable handpiece, and sterile water spray cooling. Includes red aiming beam. Manual power adjustment. No software-based automation or connectivity described.

Indications for Use

Indicated for general ophthalmic soft tissue surgery, including incision, excision, vaporization, and coagulation of ocular and periocular/orbital tissue.

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

• WaterLase (K031140, K030523, K012511, K011041)
• DermaLase (K971459)
• MSq Family of Lovely Light/Laser Systems (K042000)
• Laserscope Erbium:YAG Laser System and Accessories (K971843)
• Aesculap-Meditec MCL 29 Dermablate Erbium Laser System (K964128)
• Pfizer Laser Systems Centauri (K905141)
• Friendly Light ER:YAG Pulsed Laser (K000023)

Submission Summary (Full Text)

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JUL - 5 2006

### 510(k) Summary of Safety and Effectiveness for the Oculase MD

KOS2354

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:

BIOLASE Technology, Inc. 4 Cromwell Irvine, CA 92618.

Contact Person:

Maureen O'Connell 5 Timber Lane North Reading, MA 01864 Telephone: [phone] Fax: [phone]

Summary Preparation Date:

June 30, 2006 .

Oculase MD

2. Names

Device Name:

Classification Name:

Ophthalmic Laser Product Code: HQF

#### 3. Predicate Devices

The Oculase MD® is substantially equivalent to a combination of the following devices: BIOLASE's WaterLase® (K031140, K030523, K012511, K011041), and DermaLase™ (K971459), MSq (M2) Ltd. MSq Family of Lovely Light/Laser Systems (K042000), Laserscope's Erbium:YAG Laser System and Accessories (K971843), Aesculap-Meditec's MCL 29 Dermablate Erbium Laser System (K964128), Pfizer Laser Systems' Centauri (K905141), and the Friendly Light ER:YAG Pulsed Laser (K000023).

#### 4. Device Description

The Oculase MD Er,Cr:YSGG (Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet) tissue cutting system is a unique device with diverse ophthalmic tissue applications. A flexible fiber optic with handpiece delivers the laser wavelength to the target tissue. A red light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output may be adjusted to specific user requirements for tissue applications. Laser radiation is delivered

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from the laser unit to the handpiece through the optical fiber. A sterile water spray is emitted at the same time laser radiation is delivered to the tissue site. The handpiece is rotatable and detachable from the optical shaft. The tip is detachable from the handpiece and serves as the optical power conduit to the target tissue.

# 5. Indications for Use

The Oculase MD is indicated for use in general ophthalmic soft tissue surgical indications such as: incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

## 6. Performance Data

None presented.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, wave-like design at the bottom. Encircling the central image is text that reads 'DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA'.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 5 2006

BIOLASE Technology, Inc. % Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864

Re: K052354 Trade/Device Name: Oculase MD 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 7, 2006 Received: June 8, 2006

Dear Ms. O'Connell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the i'ddications for use stated in the enclosure) to legally marketed prodicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). 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 898. In addition, FDA evay publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act `s requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the accornit product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 – Ms. Maureen O'Connell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permitts varueday ce to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ohtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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,

Hubert Humphrey

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _ _ K052354

Device Name: _ Oculase MD

Indications for Use:

The Oculase MD may be indicated for general ophthalmic soft tissue surgical indications such as:

Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Hulur Lisan

(Division Sign-Division of General, Restorative, and Neurological Devices

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510(k) Number k052354