(90 days)
Not Found
No
The summary describes a laser system for photocoagulation and other laser treatments, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for treatments of various medical conditions such as diabetic retinopathy, glaucoma, retinal tears, and skin lesions, which are all therapeutic applications.
No
The device is described as a laser system used for various treatments, such as retinal photocoagulation and laser trabeculoplasty, which are therapeutic procedures. It does not mention any function related to diagnosing conditions.
No
The device description clearly states it is a "semiconductor-based laser" that delivers laser light, indicating it is a hardware device.
Based on the provided information, the IRIDEX OcuLight GL/GLx is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The OcuLight GL/GLx is a laser system used for treating various conditions directly on the patient's body (in vivo). It delivers laser light for procedures like photocoagulation, trabeculoplasty, and treating skin lesions.
- Intended Use: The intended use clearly describes therapeutic procedures performed on the patient, not diagnostic testing of specimens.
- Device Description: The description focuses on the laser technology and its application for treatment.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical characteristics of an IVD device.
Therefore, the IRIDEX OcuLight GL/GLx is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IRIDEX OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | Retinal Photocoagulation (RPC); Focal |
| and Grid Laser Treatments | |
| • Nonproliferative Retinopathy | |
| • Macular Edema | |
| • Proliferative Retinopathy | |
| Glaucoma | Laser Trabeculoplasty; Iridotomy, |
| Iridoplasty | |
| • Primary Open Angle | |
| • Closed Angle | |
| Retinal Tears and Detachments | RPC; Focal and Grid Laser Treatments |
| Lattice Degeneration | RPC; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | RPC; Focal and Grid Laser Treatments |
| Intra-Ocular Tumors | RPC; Focal and Grid Laser Treatments |
| • Choroidal Hemangioma | |
| • Choroidal Melanoma | |
| • Retinoblastoma | |
| Retinopathy of Prematurity | RPC; Focal and Grid Laser Treatments |
| Sub-Retinal (choroidal) Neovascularization | RPC; Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | RPC; Focal and Grid Laser Treatments |
| Dermatology | Focal Laser Treatments |
| • Pigmented Skin Lesions | |
| • Vascular lesions | |
| Ear, Nose and Throat | Stapedotomy |
| • Otosclerotic Hearing Loss |
Product codes (comma separated list FDA assigned to the subject device)
GEX, HQF
Device Description
The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Retina, Eye, Skin, Ear, Nose, Throat
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical performance Data: None
Clinical performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K960971, K982031, K020374, K022327, K962592
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
AUG 2 7 2003
510(k) Summary IRIDEX Corporation IRIS Medical® OcuLight® GL/GLx
K031665 1/3
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8848 ext. 3016
Contact Person: (same as above)
Date Prepared: May 23, 2003
Name of Device and Name/Address of Sponsor
IRIS Medical OcuLight GL/GLx Laser Systems
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Classification Name
Laser Instrument, Surgical, Powered CFR Section: 878.4810 and 886.4390 Product Code: GEX and HQF
Predicate Devices
- The OcuLight GL/GLx laser systems are substantially equivalent to other currently legally marketed ophthalmology laser devices including IRIDEX Corporation's IRIS Medical OcuLight GL Laser (K960971 and K982031), the IRIS Medical OcuLight SL/SLx Laser (K020374), the Lumenis Novus Spectra (K022327), and the Alcon Ophthalas® 532 Laser (K962592).
Device Description
The OcuLight GL/GLx is a semiconductor-based laser that delivers true continuous wave green laser (532 nm) light for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.
1
Intended Use
The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | Retinal Photocoagulation (RPC); Focal |
| and Grid Laser Treatments | |
| • Nonproliferative Retinopathy | |
| • Macular Edema | |
| • Proliferative Retinopathy | |
| Glaucoma | Laser Trabeculoplasty; Iridotomy; |
| Iridoplasty | |
| • Primary Open Angle | |
| • Closed Angle | |
| • Refractory Glaucoma | |
| Retinal Tears and Detachments | RPC; Focal and Grid Laser Treatments |
| Lattice Degeneration | RPC; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | RPC; Focal and Grid Laser Treatments |
| Intra-Ocular Tumors | RPC; Focal and Grid Laser Treatments |
| • Choroidal Hemangioma | |
| • Choroidal Melanoma | |
| • Retinoblastoma | |
| Retinopathy of Prematurity | RPC; Focal and Grid Laser Treatments |
| Sub-Retinal (choroidal) Neovascularization | RPC; Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | RPC; Focal and Grid Laser Treatments |
| Dermatology | Focal Laser Treatments |
| • Pigmented Skin Lesions | |
| • Vascular lesions | |
| Ear, Nose and Throat | Stapedotomy |
| • Otosclerotic hearing loss |
Technological Characteristics and Substantial Equivalence
The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The expansion of the indications for use for the proposed OcuLight does not result in a change to the hardware or firmware for the currently marketed OcuLight GL/GLx.
2
K0.31665 3/3
The OcuLight SL/SLx Laser Systems are indicated for Retinal Photocoagulation, Laser Trabeculoplasty, Transscleral Cyclophotocoagulation, Transscleral Retinal Photocoagulation, and other Laser Diode Treatments. The OcuLight SL/SLx diode laser systems feature a combination of pulsed diode laser and optical fiber technology to deliver the correct balance of 810 nm wavelength, spot size, and pulse duration for effective laser photocoagulation.
The Lumenis Novus Spectra Diode Laser System is indicated for many Ophthalmic, Ears, Nose and Throat, Dermatological and Dentistry applications. The Lumenis Novus Spectra delivers the same infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx.
The Alcon Ophthalas 532 Laser is indicated for use in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty. The Ophthalas 532 Laser and OcuLight GL/GLx use a variety of delivery systems, including slit lamps, indirect ophthalmoscopes, and endoprobe handpieces. The Ophthalas 532 Laser delivers a similar wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight GL/GLx.
Non-Clinical performance Data
None
Clinical performance Data
None
Conclusion
The OcuLight GL/GLx is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
AUG 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Jossy Director of Regulatory Affairs and Quality Assurancae IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043
Re: K031665
Trade/Device Name: IRIS Medical® OcuLight® GL/GLx Regulation Numbers: 21 CFR 886.4390 Regulation Names: Ophthalmic laser Regulatory Class: II Product Codes: HQF Dated: May 23, 2003 Received: May 29 2003
Dear Mr. Jossy:
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 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.
4
Page 2 - Mr. John Jossy
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Pending
Device Name: IRIS Medical® OcuLight® GL/GLX __________________________________________________________________________________________________________________________________
Indications For Use:
The IRIDEX OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, the treatment of vascular and pigmented skin lesions, and other laser treatments. The following are examples of applications for the OcuLight GL/GLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | Retinal Photocoagulation (RPC); Focal |
| and Grid Laser Treatments | |
| • Nonproliferative Retinopathy | |
| • Macular Edema | |
| • Proliferative Retinopathy | |
| Glaucoma | Laser Trabeculoplasty; Iridotomy, |
| Iridoplasty | |
| • Primary Open Angle | |
| • Closed Angle | |
| Retinal Tears and Detachments | RPC; Focal and Grid Laser Treatments |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031665
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use -------
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Pending_____________________________________________________________________________________________________________________________________________
Device Name: IRIS Medical® OcuLight® GL/GLX___________________________________________________________________________________________________________________________________
Indications For Use:
| Condition | Treatment |
|---|---|
| Lattice Degeneration | RPC; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | RPC; Focal and Grid Laser Treatments |
| Intra-Ocular Tumors | RPC; Focal and Grid Laser Treatments |
| • Choroidal Hemangioma | |
| • Choroidal Melanoma | |
| • Retinoblastoma | |
| Retinopathy of Prematurity | RPC; Focal and Grid Laser Treatments |
| Sub-Retinal (choroidal) Neovascularization | RPC; Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | RPC; Focal and Grid Laser Treatments |
| Dermatology | Focal Laser Treatments |
| • Pigmented Skin Lesions | |
| • Vascular lesions | |
| Ear, Nose and Throat | Stapedotomy |
| • Otosclerotic Hearing Loss |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K03/665
Prescription Use .
OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________