20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25

K021696 · Ophthalmed, LLC · GEX · Aug 20, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021696
• Device Name: 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
• Applicant: Ophthalmed, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for use to perform laser photocoagulation treatments inside the eye (i.e., panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, laser trabeculoplasty), during surgical interventions (e.g.: trans pars plana vitrectomy). The operating wavelength is 514 to 532 nm.

Device Story

Device consists of ophthalmic laser fiber delivery system; includes handpiece with 20G or 25G extension, 6 ft fiber, and connector for laser source; flexible plastic jacket covers fiber. Used by ophthalmologists during surgical interventions (e.g., trans pars plana vitrectomy) to deliver laser energy (514-532 nm) for photocoagulation treatments inside the eye. Fiber tip guides laser energy to target ocular tissues; enables precise photocoagulation; benefits patient by facilitating minimally invasive intraocular surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparative analysis of technological characteristics, materials, and performance specifications against the predicate device.

Technological Characteristics

Ophthalmic laser fiber delivery system; 20G or 25G tip extension; 6 ft fiber length; flexible plastic jacket; SMA connector. Operates at 514-532 nm wavelength. Sterilized via Ethylene Oxide. No active electronic or software components; passive fiber optic delivery.

Indications for Use

Indicated for patients requiring intraocular laser photocoagulation treatments, including panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, and laser trabeculoplasty during surgical interventions such as trans pars plana vitrectomy.

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

• LightLas 532 Ophthalmic Photocoagulator Laser (K010372)

Submission Summary (Full Text)

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K021696

# 510(k) Summary As Required by 21 section 807.92 ( c )

AUG 2 0 2002

1-Submitter Name: OphthalMed LLC

1308 Morningside Park Dr 2-Address:

Alpharetta, GA 30022 USA

3-Phone: [phone]

(425) 795- 9341 4-Fax:

5-Contact Person: Jay Mansour

6-Date summary prepared: April 8th, 2002

7-Device Trade or Proprietary Name: 20g and 25g SMA Laser Fibers

8-Device Common or usual name: Ophthalmic laser

9-Device Classification Name: Ophthalmic laser

10-Substantial Equivalency is claimed against the following device:

LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (510k #K010372) Refer to Appendix 1 for details.

### 11-Description of the Device:

This device consists of the following parts already connected to each other:

- Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber.
- A special connector that attaches the fiber end to the laser source.
- A flexible plastic jacket covers the length of the fiber.

#### 12-Intended use of the device:

This device is indicated for use to perform laser photocoagulation treatments inside the eye (i.e., panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, laser trabeculoplasty), during surgical interventions (e.g.: trans pars plana vitrectorny). The operating wavelength is 514 to 532 nm.

#### 13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

#### 14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.

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| FDA file reference number | 510k 010372 |
|-----------------------------------------------------|----------------------------|
| Attachments inside notification<br>submission file | Appendix 1 to 5 |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide) |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment<br>and other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |

.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 0 2002

Mr. Jay Mansour Director, QA/RA OpthalMed LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022

Re: K021696

Trade/Device Name: 20G SMA Laser Fiber, Model LF20; 25G SMA Laser Fiber, Model LF25 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: GEX Dated: May 16, 2002 Received: May 22, 2002

Dear Mr. Mansour:

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. Iisting 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 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); 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.

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Page 2 - Mr. Jay Mansour

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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html .

Sincerely yours,

Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (il known): 502 1696 (20g & 25 g Device Name: SHA LASER FINER Indications For Use:

THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliman
Division Sign Off

ivision Sign-Off) on of General, Restorative and Neurological

Prescription Use.............................................................................................................................................................. 216 9 Vest - 11

(Optional Formal 1-2-96)

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