(42 days)
Lumenis Novus Spectra (K022327)
Not Found
No
The provided text describes a laser device for various medical procedures and does not mention any AI or ML capabilities.
Yes
The device is used to treat various medical conditions, including diabetic retinopathy, glaucoma, retinal tears and detachments, AMD, and tumors, which are all therapeutic applications.
No
The device is described as a "semiconductor-based laser" for delivering "continuous wave green laser light" for various treatments, such as retinal photocoagulation and laser trabeculoplasty. Its intended uses are all therapeutic procedures (e.g., "Retinal Photocoagulation," "Laser Trabeculoplasty," "Iridotomy"), rather than for diagnosing conditions.
No
The device description clearly states that the OcuLight GL/GLx 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 In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The OcuLight GL/GLx is a laser system that delivers light energy directly to anatomical sites (retina, skin, ear, nose, throat) for therapeutic purposes (photocoagulation, laser treatments, surgical procedures). It is used to treat conditions, not to analyze samples from the body.
- Intended Use: The intended uses listed are all direct treatments or procedures performed on the patient's body.
Therefore, the IRIDEX OcuLight GL/GLx falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | |
| • Nonproliferative Retinopathy | |
| • Macular Edema | |
| • Proliferative Retinopathy | Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments |
| Glaucoma | |
| • Primary Open Angle | |
| • Closed Angle | Laser Trabeculoplasty; Iridotomy, Iridoplasty |
| 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 | |
| • Choroidal Hemangioma | |
| • Choroidal Melanoma | |
| • Retinoblastoma | RPC; Focal and Grid Laser Treatments |
| 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 | |
| • Pigmented Skin Lesions | |
| • Vascular lesions | Focal Laser Treatments |
| Ear, Nose and Throat | |
| • Otosclerotic hearing loss and/or diseases of the inner ear | Stapedectomy |
| Stapedotomy | |
| Myringotomies | |
| Lysis of Adhesions | |
| Control of Bleeding | |
| Removal of Acoustic Neuromas | |
| Soft tissue Adhesion in Micro/Macro Otologic Procedures |
Product codes (comma separated list FDA assigned to the subject device)
GEX and 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
Retinal, Ophthalmic, Skin, Ear, Nose, Throat, Inner Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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.
Lumenis Novus Spectra (K022327)
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
APR 1 4 2005
510(k) Summary IRIDEX Corporation IRIS Medical® OcuLight® GL/GLx
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 Ocutiight SLASLASE systems and the Lumenis Novus Spectra (K022327).
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, iridotomy, iridoplasty, the treatment of vascular and pigmented skin lesions, stapedotomy, stapedectomy, and other ear, nose, and throat (ENT) applications. 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 | |
| Otosclerotic hearing loss and/or diseases | |
| of the inner ear | Stapedectomy |
| Stapedotomy | |
| Myringotomies | |
| Lysis of Adhesions | |
| Control of Bleeding | |
| Removal of Acoustic Neuromas | |
| Soft tissue Adhesion in Micro/Macro | |
| Otologic | |
| Procedures |
2
Technological Characteristics and Substantial Equivalence
The OcuLight GL/GLx is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty, the treatment of vascular and pigmented skin lesions, stapedotomy, stapedectomy, and other ENT applications. 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.
The OcuLight SL/SLx Laser Systems are indicated for Retinal Photocoagulation, Laser Trabeculoplasty, Transscleral Cyclophotocoagulation (TSCPC), Transscleral Retinal Photocoagulation (TSRPC), Iridotomy, and Iridoplasty. 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 (including stapedectomy), Dermatological and Dentistry applications. The Lumenis Novus Spectra delivers the same 532nm 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 the predicate devices currently legally marketed for stapedotomy, stapedectomy, and other ENT applications as shown in the Indications for Use statement.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2005
IRIDEX Corporation c/o John Jossy Director of Regulatory Affairs and Quality Assurance 1212 Terra Bella Avenue Mountain View, CA 04043
Re: K050562
Trade/Device Name: IRIS Medical OcuLight GL/GLx Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 4, 2005 Received: March 8, 2005
Dear Mr. Jossy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back at 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 r that FDA has made a determination that your device complies with other requirements of the Act that I D. I has intacted and regulations administered by other Federal agencies. You must or any I cuttar statutes and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quants of byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Kosos62 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): Pending_____________________________________________________________________________________________________________________________________________
Device Name: IRIS Medical® OcuLight® GL/GLx
Indications For Use:
The IRIDEX OcuLight GL/GLx is used in ophthalmic, dermatology, and ear nose and throat (ENT) applications. Specific indications are listed below:
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | |
| • Nonproliferative Retinopathy | |
| • Macular Edema | |
| • Proliferative Retinopathy | Retinal Photocoagulation (RPC); Focal and Grid Laser Treatments |
| Glaucoma | |
| • Primary Open Angle | |
| • Closed Angle | Laser Trabeculoplasty; Iridotomy, Iridoplasty |
| 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)
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 | |
| • Choroidal Hemangioma | |
| • Choroidal Melanoma | |
| • Retinoblastoma | RPC; Focal and Grid Laser Treatments |
| 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 |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Bending Kosos 62 2 2 2 2 2 2 2 2 2 2 ----------
Device Name: IRIS Medical® OcuLight® GL/GLx___________________________________________________________________________________________________________________________________
Indications For Use:
| Condition | Treatment |
|---|---|
| Dermatology | |
| • Pigmented Skin Lesions | |
| • Vascular lesions | Focal Laser Treatments |
| Ear, Nose and Throat | |
| • Otosclerotic hearing loss and/or diseases of the inner ear | Stapedectomy |
| Stapedotomy | |
| Myringotomies | |
| Lysis of Adhesions | |
| Control of Bleeding | |
| Removal of Acoustic Neuromas | |
| Soft tissue Adhesion in Micro/Macro Otologic Procedures |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| OR | |
| (Per 21 CFR 801.109) |
forex & to hom
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________