(170 days)
No
The summary describes a traditional laser photocoagulator and its delivery devices, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is intended for "retinal photocoagulation and laser trabeculoplasty," which are medical procedures performed to treat conditions and restore health to the eye. This aligns with the definition of a therapeutic device.
No
The device is described as an "ophthalmic laser photocoagulator" used for "retinal photocoagulation and laser trabeculoplasty." These are treatment procedures, not diagnostic ones. Its function is to deliver laser light for treatment, not to diagnose conditions.
No
The device description explicitly states it is a "semiconductor-based ophthalmic laser photocoagulator," indicating it is a hardware device that delivers laser light. It also mentions being used with "fiber optically coupled delivery devices," which are also hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is a laser photocoagulator used to treat the retina directly within the patient's eye.
- The intended use is a therapeutic procedure (retinal photocoagulation and laser trabeculoplasty). IVD devices are used for diagnostic purposes, analyzing samples to provide information about a patient's health.
- The device description clearly states it delivers laser light for treatment. There is no mention of analyzing biological samples.
Therefore, based on the provided information, this device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.
Product codes
86 HOF
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K912918, K913430, K894841, K903288
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.
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AIG 28 MB
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 HOF
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).
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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: Y AG laser which is optically pumped by arc lamps and acousto-optically Qswitched. 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).