OCULIGHT GL
K960971 · Iriderm Div. · HQF · Aug 28, 1996 · Ophthalmic
Device Facts
| Record ID | K960971 |
|---|
| Device Name | OCULIGHT GL |
|---|
| Applicant | Iriderm Div. |
|---|
| Product Code | HQF · Ophthalmic |
|---|
| Decision Date | Aug 28, 1996 |
|---|
| Decision | SESE |
|---|
| Submission Type | Traditional |
|---|
| Regulation | 21 CFR 886.4390 |
|---|
| Device Class | Class 2 |
|---|
| Attributes | Therapeutic |
|---|
Intended Use
The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.
Device Story
Semiconductor-based laser photocoagulator console; delivers true continuous wave green laser light (532 nm) for retinal photocoagulation and laser trabeculoplasty. Input: infrared (808 nm) semiconductor diode laser energy converted to 532 nm green light; aiming beam provided by red (630-650 nm) semiconductor CW laser. Used in clinical settings by ophthalmologists. Operates via fiber-optic coupling to cleared delivery devices: slit lamp adapter, endophotocoagulation probes, and laser indirect ophthalmoscope. Output: controlled laser energy for tissue coagulation. Clinical benefit: enables precise ocular tissue treatment for retinal conditions and glaucoma management.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Semiconductor-based laser photocoagulator. Primary source: 808 nm infrared diode laser, wavelength-converted to 532 nm green output. Aiming beam: 630-650 nm red semiconductor CW laser. Delivery: fiber-optically coupled to slit lamp adapters, endoprobes, or indirect ophthalmoscopes. Energy: true continuous wave. Standalone console.
Indications for Use
Indicated for retinal photocoagulation and laser trabeculoplasty in patients requiring ophthalmic laser treatment, performed by an ophthalmologist.
Regulatory Classification
Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
Predicate Devices
- IRIS Medical OcuLight SL Laser Photocoagulator System (K894841)
- Coherent Novus 2000 Laser Photocoagulator system (K913127)
- Alcon Ophthalas 532 Laser Photocoagulator System (K932062)
Reference Devices
- IRIS Slit Lamp Adapter (K912918)
- IRIS Slit Lamp Adapter (K913430)
- IRIS EndoProbe (K894841)
- IRIS Laser Indirect Ophthalmoscope (K903288)
Related Devices
- K031665 — IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS · Iridex Corp · Aug 27, 2003
- K040209 — IRIS MEDICAL IQ 810 PHOTOCOAGULATOR · Iridex Corp · Sep 20, 2004
- K072514 — VISULAS TRION · Carl Zeiss Meditec, AG · Sep 21, 2007
- K032357 — NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES · Lumenis, Inc. · Oct 9, 2003
- K972514 — LASEREX LP1532 PHOTOCOAGULATOR · Ellex Medical Pty, Ltd. · Oct 3, 1997
Submission Summary (Full Text)
{0}
AUG 28 1996
K960971
510(k) Summary
IRIS Medical Instruments, Inc.
OcuLight GL
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Theodore A. Boutacoff
IRIS Medical Instruments, Inc.
340 Pioneer Way
Mountain View, CA 94041
415-962-8100
Contact Person: (same as above)
Date Prepared: March 7,1996
Name of Device and Name/Address of Sponsor
OcuLight GL
IRIS Medical Instruments, Inc.
340 Pioneer Way
Mountain View, CA 94041
Classification Name
Ophthalmic Laser Photocoagulator
CFR Section: 886.4390
Product Code: 86 HQF
Predicate Devices
The OcuLight GL Laser Photocoagulator system is substantially equivalent to other currently legally marketed laser photocoagulator devices including IRIS Medical OcuLight SL Laser Photocoagulator System (K894841), the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062).
Page 1
{1}
Page 2
# Intended Use
The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.
# Technological Characteristics and Substantial Equivalence
The OcuLight GL is a semiconductor-based laser photocoagulator console which delivers true continuous wave green laser light. The OcuLight GL uses infrared (808 nm) semiconductor diode laser light as the primary source of energy which is then wavelength converted to a visible green (532 nm) laser light for delivery to the patient's eye and treatment. A second visible red (630-650 nm) semiconductor CW laser is used for aiming.
The OcuLight GL is substantially equivalent to other currently legally marketed laser photocoagulator devices including the Coherent Novus 2000® Laser Photocoagulator system (K913127); the Alcon Ophthalas® 532 Laser Photocoagulator System (K932062); as well as the IRIS Medical OcuLight SL Laser Photocoagulator System (K894841). All of these predicate devices are indicated for retinal photocoagulation using slit lamp delivery, endophotocoagulation probes, and the laser indirect ophthalmoscope; and for laser trabeculoplasty using slit lamp delivery. The Coherent Novus 2000 uses an argon gas laser as the treatment laser. The colors of the treatment beam are blue (488 nm) and green (514 nm). A moving filter is used to restrict delivery of only green laser light when desired. Power delivered is true continuous wave. The color of the treatment beam for the Alcon Ophthalas 532 is green (532 nm). This beam is generated from a frequency-doubled Nd:YAG laser which is optically pumped by arc lamps and acousto-optically Q-switched. Power delivered is pulsed. The color of the treatment beam for the IRIS Medical OcuLight SL is infrared (810 nm). This beam is generated directly from a semiconductor laser diode. Power delivered is true continuous wave.
# Device Description
The OcuLight GL is a semiconductor-based ophthalmic laser photocoagulator which delivers true continuous wave green laser light. It will only be used in conjunction with three fiber optically coupled delivery devices which have received prior FDA-premarket clearance: the IRIS Slit Lamp Adapter (K912918 for retinal photocoagulation and K913430 for laser trabeculoplasty), the IRIS EndoProbe (K894841), and the IRIS Laser Indirect Ophthalmoscope (K903288).
