PASCAL PHOTOCOAGULATOR, PASCAL-US

K091666 · Optimedica Corporation · GEX · Jul 15, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091666
• Device Name: PASCAL PHOTOCOAGULATOR, PASCAL-US
• Applicant: Optimedica Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy . - macular edema . - choroidal neovascularization . - branch and central retinal vein occlusion . - age-related macular degeneration . - . lattice degeneration - retinal tears and detachments . - iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

Device Story

PASCAL Photocoagulator is an integrated ophthalmic laser system; includes solid-state aiming and treatment lasers, control electronics, graphical user interface (GUI), slit-lamp, and table. Used by ophthalmologists in clinical settings to perform retinal and anterior segment photocoagulation. System delivers laser energy to ocular tissues to treat vascular and structural abnormalities. Modifications from predicate include updated performance specifications, scan patterns, outer housing, and software. Device provides controlled laser delivery to target tissue; assists physician in managing conditions like diabetic retinopathy and glaucoma. Benefits include precise, automated pattern delivery for ocular pathology treatment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Integrated system with solid-state aiming and treatment lasers, control electronics, GUI, slit-lamp, and table. Features modified scan patterns and software. Class II device.

Indications for Use

Indicated for patients requiring treatment of ocular pathology in posterior and anterior segments, including diabetic retinopathy, macular edema, choroidal neovascularization, retinal vein occlusions, age-related macular degeneration, lattice degeneration, retinal tears/detachments, and glaucoma (iridotomy, iridectomy, trabeculoplasty).

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

• PASCAL Photocoagulator (K043486)

Submission Summary (Full Text)

{0}------------------------------------------------

OptiMedica Corporation

PASCAL® PHOTOCOAGULATOR SPECIAL 510(k) PREMARKET NOTIFICATION

## SECTION 6 510(k) SUMMARY (CONT.)

# 510(k) Notification K ( 99 1666

5

### GENERAL INFORMATION

### Applicant:

OptiMedica Corporation 3130 Coronado Drive Santa Clara, CA 95054 USA Phone: [phone] FAX: [phone]

### Contact Person:

Darlene Crockett-Billig Regulatory Consultant for OptiMedica Corporation 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 USA Phone: [phone] ext. 105 FAX: [phone] Email: [e-mail]

## Date Prepared: June 5, 2009

#### Classification:

21 CFR§878.4810, Class II 21 CFR§886.4390, Class II

### Product Code: GEX, HQF

GEAR, HQ1

Trade Name: PASCAL® Photocoagulator

### Generic/Common Name: Laser instrument, surgical, powered Laser, ophthalmic

Predicate Device PASCAL Photocoagulator (K043486)

# JUL 1 5 2009

#### CONFIDENTIAL

25

{1}------------------------------------------------

## SECTION 6 510(k) SUMMARY (CONT.)

#### Intended Use

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

- proliferative and nonproliferative diabetic retinopathy .
- macular edema .
- choroidal neovascularization .
- branch and central retinal vein occlusion .
- age-related macular degeneration .
- . lattice degeneration
- retinal tears and detachments .
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle . glaucoma.

#### Product Description

The PASCAL Photocoagulator is an integrated system comprising of solid state aiming and treatment lasers, control electronics, graphical user interface, slit-lamp and table. It is intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

The proposed PASCAL Photocoagulator includes design modifications to the performance specifications, available scan patterns, outer housing and software to enhance product performance. No changes to the laser or the product safety have been made. The PASCAL Photocoagulator maintains the same indication for use as the predicate device, the PASCAL Photocoagulator (K043486).

#### Substantial Equivalence

The PASCAL Photocoagulator is substantially equivalent to the predicate device with regard to function, intended use and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the proposed PASCAL Photocoagulator is substantially equivalent to the predicate device.

## Testing in Support of Substantial Equivalence Determination

All necessary bench testing was conducted on the proposed PASCAL Photocoagulator to support a determination of substantial equivalence to the predicate device.

#### Summarv

The PASCAL Photocoagulator is substantially equivalent to the predicate device.

#### CONFIDENTIAL

{2}------------------------------------------------

### 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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird-like figure with three curved lines forming its body and wings. The emblem is black, and the text is also in a dark color, likely black or a dark shade of gray.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2009

Optimedica Corporation c/o Experien Group LLC. Darlene Crockett-Billig 155-A Moffit Park Drive, Suite 210 Sunnyvale, CA 94089

Re: K091666

Trade/Device Name: PASCAL Photocoagulator Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II . Product Code: GEX Dated: June 30, 2009 Received: July 1, 2009

Dear Ms. Crockett-Billig

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 indications for use stated in the enclosure) to legally marketed predicate 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 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 may 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

## Page 2 - Darlene Crockett-Billig

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain 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,

urs,

lkerson

Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

OptiMedica Corporation

### SECTION 5 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _ K 09 166 b

Device Name: PASCAL® Photocoagulator

Intended for use in the treatment of ocular pathology in both the posterior and anterior segments.

Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

- proliferative and nonproliferative diabetic retinopathy .
- . macular edema
- choroidal neovascularization .
- branch and central retinal vein occlusion .
- age-related macular degeneration .
- lattice degeneration
- retinal tears and detachments
- iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Eya

\$\frac{\text{RP} \text{Sale}}{\text{(Division Sign-Off)}}\$

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091666