OCULIGHT SL/SLX

K020374 · Iridex Corp · HQF · May 3, 2002 · Ophthalmic

Device Facts

• Record ID: K020374
• Device Name: OCULIGHT SL/SLX
• Applicant: Iridex Corp
• Product Code: HQF · Ophthalmic
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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. 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.

Device Story

Semiconductor diode laser system; delivers pulsed infrared 810 nm laser light for therapeutic photocoagulation; visible red 630-650 nm laser used for aiming. Used by ophthalmologists in clinical settings; compatible with various delivery systems including slit lamps, indirect ophthalmoscopes, endoprobes, and transscleral probes. Device transforms electrical energy into therapeutic laser output; output intensity and duration controlled by physician to achieve desired tissue photocoagulation. Benefits include minimally invasive treatment of various retinal and glaucomatous conditions. No change to hardware or firmware from previous versions; expansion of indications only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semiconductor diode laser; 810 nm infrared therapeutic wavelength; 630-650 nm red aiming beam. Delivery via slit lamps, indirect ophthalmoscopes, endoprobes, and transscleral probes. Powered surgical laser instrument. Class II device.

Indications for Use

Indicated for patients requiring retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, or transscleral retinal photocoagulation for conditions including diabetic retinopathy, glaucoma, retinal tears/detachments/holes, lattice degeneration, AMD, intra-ocular tumors, retinopathy of prematurity, sub-retinal neovascularization, and retinal vein occlusion.

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/SLx Laser Photocoagulators (K894841 and K913430)
• IRIS Medical OcuLight GL Laser Photocoagulator (K960971)
• Keeler Instruments Microlase (K890086)
• Nidek DC-3300 Laser Diode Photocoagulation (K013760)

Submission Summary (Full Text)

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### 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 [phone] 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.

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### 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);<br>Focal and Grid Laser Treatments |
| Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma<br>(recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy;<br>Transscleral Cyclophotocoagulation (TSCPC) |
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation (TSRPC); Focal and Grid Laser<br>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<br>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.

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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.

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#### 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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<br>(TSCPC) |
| • Closed Angle | |
| • Refractory Glaucoma<br>(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 _________________________________________________________________________________________________________________________________________________________

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.

.

# INDICATIONS FOR USE STATEMENT

.

| 510(k) Number (if known): | <s>Pending</s> K020374 |
|---------------------------|------------------------|
|---------------------------|------------------------|

Device Name: IRIS Medical® OcuLight® SL/SLx___________________________________________________________________________________________________________________________________

Indications For Use:

| Condition | Treatment |
|--------------------------------------------|-----------------------------------------------------------------------------------|
| Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation<br>(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<br>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 _________________________________________________________________________________________________________________________________________________________