Who is the manufacturer of OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS?

Alcon Laboratories filed the 510(k) submission for OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS (K962592).

What is the FDA product code for OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS?

Ophthalas 532 Photocoagulator (Alcon Laboratories); Blue-green Argon Ophthalmic Lasers.

Who can help prepare an FDA 510(k) submission like OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS

K962592 · Alcon Laboratories · GEX · Sep 23, 1996 · General, Plastic Surgery

Device Facts

Record ID	K962592
Device Name	OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS
Applicant	Alcon Laboratories
Product Code	GEX · General, Plastic Surgery
Decision Date	Sep 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

Device Story

Ophthalas 532 is a pulsed solid-state frequency-doubled Nd:YAG laser; produces 532 nm green therapeutic beam via harmonic generation through non-linear optical crystal; includes 633 nm HeNe aiming beam and 1064 nm infrared beam. Used in ophthalmic surgery by physicians to create thermal lesions. Operates similarly to conventional Argon lasers for retinal/macular photocoagulation, cyclophotocoagulation, sclerostomy, iridotomy, and trabeculoplasty. Provides precise thermal tissue effects for ocular treatment.

Clinical Evidence

Bench testing only; performance data demonstrates the device consistently and safely produces thermal lesions equivalent to those produced by conventional Argon lasers.

Technological Characteristics

Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser; frequency-doubled to 532 nm green beam; 633 nm HeNe aiming beam; 1064 nm infrared beam. Uses non-linear optical dielectric crystal for harmonic generation.

Indications for Use

Indicated for ophthalmic surgical procedures requiring photocoagulation, including retinal/macular photocoagulation, transcleral cyclophotocoagulation, internal sclerostomy, iridotomy, and 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

Ophthalas 532 Photocoagulator (Alcon Laboratories)
Blue-green Argon Ophthalmic Lasers

Related Devices

K980547 — NIDEK PRIMA MODEL GYC-1500/2000 · Nidek, Inc. · May 13, 1998
K062624 — NEXT GENERATION LASER · Alcon Laboratories · Nov 5, 2007
K972514 — LASEREX LP1532 PHOTOCOAGULATOR · Ellex Medical Pty, Ltd. · Oct 3, 1997
K091534 — LIGHTLAS MODEL 532 · Lightmed Corp. · Sep 18, 2009
K990725 — NUVOLASE 532 LASER SYSTEM · American Laser Corp. · Mar 22, 1999

Submission Summary (Full Text)

{0} SEP 23 1996 K962592 Alcon LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TX 76134 (817) 551-8388 May 14, 1996 510(K) SUMMARY Submitted by: Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax) Trade Name: Ophthalas® 532 Solid State Photocoagulator Common Name: Solid state ophthalmic laser photocoagulator Classification Name: Ophthalmic Laser (per 21 CFR 886.4390) {1} K962592 # 1. Predicate Device The legally marketed device(s) to which we are claiming equivalence to are the Ophthalas® 532 Photocoagulator marketed by Alcon Laboratories, and blue-green Argon Ophthalmic Lasers cleared for the Trabeculoplasty indication. # 2. Device Description The Ophthalas 532 Solid State Photocoagulator, and/or equivalent devices, are a pulsed solid state frequency doubled Nd:YAG laser producing a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam. A 633 nm helium-neon (HeNe) laser is used for the aiming beam source. # 3. Intended Use of the Device The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty. # 4. Summary of the Technological Characteristics of the Device The Ophthalas 532 is a Neodymium-doped Yttrium Aluminum Garnet type laser which has been designed for ophthalmic use. LASER is an acronym for “Light Amplified by Stimulated Emission of Radiation.” This laser delivers a 532 nm green laser beam (frequency doubled), a 633 nm HeNe (Helium-Neon) aiming beam, and a 1064 nm infrared laser beam. The laser beam may be defined as a visible (i.e.; green 532 nm) or invisible (i.e.; 1064 nm), coherent monochromatic light beam. The doubling process of the 1064 wavelength results when the infrared beam goes through a special crystal. The crystal is an optical dielectric that exhibits a non-linear optical response. The 532nm wavelength is produced by harmonic generation of the 1064nm laser beam. # 5. Summary of the Performance Data The Ophthalas 532 Laser consistently and safely produces a thermal lesion equivalent to those produced by conventional Argon lasers. # 6. Conclusions The Ophthalas 532 Laser is substantially equivalent to Argon lasers for the treatment of all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty.