(88 days)
Not Found
No
The summary describes a laser system for photocoagulation and other laser treatments, focusing on the laser technology and its applications. There is no mention of AI or ML in the intended use, device description, or other sections.
Yes
The device is indicated for various medical treatments, including retinal photocoagulation, laser trabeculoplasty, and transscleral cyclophotocoagulation, which are therapeutic interventions.
No
The device description and intended use clearly state that the IRIDEX OcuLight SL/SLx is used for various laser treatments (e.g., photocoagulation, laser trabeculoplasty) for specific conditions, which are therapeutic interventions rather than diagnostic procedures.
No
The device description explicitly states it is a "semiconductor diode laser system," indicating it is a hardware device that delivers laser light for treatment.
Based on the provided information, the IRIDEX OcuLight SL/SLx is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The IRIDEX OcuLight SL/SLx is a laser system that delivers light directly to the eye for therapeutic purposes (photocoagulation, trabeculoplasty, cyclophotocoagulation, etc.). It is used to treat various eye conditions by directly interacting with the tissue.
- Lack of Specimen Examination: The device does not examine any specimens (blood, tissue, etc.) derived from the human body outside of the body. Its action is directly on the patient's eye.
- Therapeutic Purpose: The primary purpose of the device is therapeutic treatment, not diagnostic information derived from in vitro analysis.
Therefore, the IRIDEX OcuLight SL/SLx falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IRIDEX OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the OcuLight SL/SLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments |
| Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma (recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy; Transscleral Cyclophotocoagulation (TSCPC) |
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser Treatments |
| Lattice Degeneration | PRP; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | Focal and Grid Laser Treatments |
| Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | Focal and Grid Laser Treatments |
| Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser Treatments |
| Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments |
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
Device Description
The OcuLight SL/SLx is a semiconductor diode laser system that delivers pulsed infrared 810 nm laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode 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
Not Found
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)
Not Found
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.
K894841, K913430, K960971, K890086, K013760
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
510(k) Summary IRIDEX Corporation IRIS Medical® OcuLight® SL/SLx
KD20374 1/3
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
John D'Angelo IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8848 ext. 3905
Contact Person: (same as above)
Date Prepared: April 23, 2002
Name of Device and Name/Address of Sponsor
IRIS Medical OcuLight SL/SLx
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Classification Name
Laser Instrument, Surgical, Powered CFR Section: 886.4390 Product Code: HQF
Predicate Devices
The OcuLight SL/SLx laser systems for the expanded indication of iridotomy are substantially equivalent to other currently legally marketed ophthalmology laser devices including IRIDEX Corporation's IRIS Medical OcuLight SL/SLx Laser Photocoagulators (K894841 and K913430), the IRIS Medical OcuLight GL Laser Photocoagulator (K960971), the Keeler Instruments, Microlase (K890086), and the Nidek, DC-3300 Laser Diode Photocoagulation (K013760).
Device Description
The OcuLight SL/SLx is a semiconductor diode laser system that delivers pulsed infrared 810 nm laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments. Visible red (630-650 nm) semiconductor diode laser is used for aiming.
1
Intended Use
The OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, The Ocalign DE SEA to mulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the OcuLight SL/SLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); |
| Focal and Grid Laser Treatments | |
| Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma | |
| (recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy; |
| Transscleral Cyclophotocoagulation (TSCPC) | |
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser |
| Treatments | |
| Lattice Degeneration | PRP; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | Focal and Grid Laser Treatments |
| Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | Focal and Grid Laser Treatments |
| Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser |
| Treatments | |
| Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments |
Technological Characteristics and Substantial Equivalence
The OcuLight SL/SLx Laser System is indicated for retinal photocoagulation, laser trabeculoplasty, TSCPC, and TSRPC. 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.
2
The OcuLight GL Laser System is indicated for retinal photocoagulation and laser trabeculoplasty. The OcuLight GL is a semiconductor-based ophthalmic laser photocoagulator that delivers true continuous wave green laser (532 nm) light.
The OcuLight GL delivers similar power, use similar delivery devices, and have similar indications as the OcuLight SL/SLx.
The Keeler Instruments Microlase Diode Laser System is indicated for retinal photocoagulation. The Microlase diode laser system delivers a wavelength of 780 to 840 nm infrared laser light.
The Microlase delivers the same infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight SL/SLx.
The Nidek DC-3300 Laser Diode Photocoagulation is indicated for all retinal photocoagulation procedures. The DC-3300 and OcuLight SL/SLx use a variety of delivery systems, including slit lamps, indirect ophthalmoscopes, endoprobes, and transscleral probes.
The DC-3300 delivers a similar infrared wavelength, pulses of equivalent duration, treatment spots of equivalent size, and energy densities equivalent to the OcuLight SL/SLx.
Non-Clinical performance Data
None
Clinical performance Data
None
Conclusion
The OcuLight SL/SLx is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 3 2002
Mr. John D'Angelo Vice President, Regulatory Affairs and Ouality Assurance IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043
Re: K020374
Trade/Device Name: IRIS Medical® OcuLight® SL/SLx Regulation Number: 886.4390 and 878.4810 Regulation Name: Ophthalmic laser and laser surgical instrument Regulatory Class: II Product Code: HQF and GEX Dated: January 30, 2002 Received: February 4, 2002
Dear Mr. D'Angelo:
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 D'Angelo
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
for 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
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): Pending | K020374 |
|---|---|
| ----------------------------------- | --------- |
Device Name: IRIS Medical® OcuLight® SL/SLx
Indications For Use:
The IRIDEX OcuLight SL/SLx is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other diode laser treatments. The following are examples of applications for the OcuLight SL/SLx laser systems.
| Condition | Treatment |
|---|---|
| Diabetic Retinopathy | Panretinal Photocoagulation (PRP); Focal |
| • Nonproliferative Retinopathy | and Grid Laser Treatments |
| • Macular Edema | |
| • Proliferative Retinopathy | |
| Glaucoma | Laser Trabeculoplasty; Iridotomy; |
| • Primary Open Angle | Transscleral Cyclophotocoagulation |
| (TSCPC) | |
| • Closed Angle | |
| • Refractory Glaucoma | |
| (recalcitrant/uncontrolled) |
(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 Sigi-On), Restorative Division of Coccal Devices
510(k) Number K020374
Prescription Use _
OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
6
.
.
INDICATIONS FOR USE STATEMENT
.
| 510(k) Number (if known): | Pending K020374 |
|---|---|
| --------------------------- | ------------------------ |
Device Name: IRIS Medical® OcuLight® SL/SLx___________________________________________________________________________________________________________________________________
Indications For Use:
| Condition | Treatment |
|---|---|
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation |
| (TSRPC); Focal and Grid Laser Treatments | |
| Lattice Degeneration | PRP; Focal and Grid Laser Treatments |
| Age-related Macular Degeneration (AMD) | Focal and Grid Laser Treatments |
| Intra-Ocular Tumors | Focal and Grid Laser Treatments |
| • Choroidal Hemangioma | |
| • Choroidal Melanoma | |
| • Retinoblastoma | |
| Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser |
| Treatments | |
| Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments |
| Central and Branch Retinal Vein Occlusion | PRP; 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)
Miriam C. Provost
(Division Sign-Off) (Division Sigil-On)
Division of General, Restorative
Division of General, Devices Division of General, and Neurological Devices
510(k) Number K020374
X Prescription Use __
OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________