FAMILI OF IRIDEX IQ LASER SYSTEMS

K071687 · Iridex Corp · GEX · Aug 7, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K071687
• Device Name: FAMILI OF IRIDEX IQ LASER SYSTEMS
• Applicant: Iridex Corp
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™,or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of , dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: [List of specific indications for 532nm, 577nm, 630-670nm, and 810nm follows].

Device Story

IRIDEX IQ Laser Systems (532nm, 577nm, 630-670nm, 810nm) deliver laser energy via fiber-optic delivery devices (probes, handpieces, LIOs). System includes main console with control panel, footswitch, and remote control. Operates in CW-pulse, MicroPulse™, or LongPulse™ modes. Used by physicians in clinical settings for ophthalmic, dermatologic, and ENT procedures. Console controls power, interval, and duration; provides visual feedback. Laser energy targets tissue for coagulation, ablation, or incision. Benefits include precise tissue management and hemostasis. Safety features include emergency stop, key switch, and smart key port for accessory identification.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics and indications for use to legally marketed predicate devices.

Technological Characteristics

Laser surgical system; wavelengths 532nm, 577nm, 630-670nm, 810nm. Fiber-optic delivery. Modes: CW-pulse, MicroPulse™, LongPulse™. Complies with 21 CFR 1040.10 and 1040.11. Console includes control panel, footswitch, remote control, and smart key port for accessory identification.

Indications for Use

Indicated for patients requiring soft/fibrous tissue incision, excision, coagulation, vaporization, ablation, or vessel hemostasis. Specialties include dermatology (pigmented/vascular lesions), ENT/otolaryngology (otosclerotic hearing loss, stapedectomy, stapedotomy, myringotomies, lysis of adhesions, acoustic neuroma removal), and ophthalmology (diabetic retinopathy, macular edema, retinal tears/detachments, lattice degeneration, AMD, retinopathy of prematurity, choroidal neovascularization, retinal vein occlusion, glaucoma).

Regulatory Classification

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.

Predicate Devices

• IRIS Medical OcuLight TX
• IRIS Medical IQ 810 Diode Laser
• IRIS Medical OcuLight GL/GLx
• Asclepion Meditec AG Laser System Yellow Star
• Lumenis Novus Varia Ophthalmic Laser
• IRIDEX OtoProbe
• IRIDEX D'Amico\Peyman Fluted EndoProbe
• Straight and Illuminating LaserProbes Adjustable Intuitive
• IRIDEX IRIS Medical G-Probe Handpieces
• IRIDEX IRIS Medical DioPexy Probe Handpieces
• IRIDEX Wireless Footswitch

Submission Summary (Full Text)

{0}------------------------------------------------

# Section 1-510(k) Summary Statement K071687

AUG - 7 2008

#### I. General Information

| Submitter: | IRIDEX Corporation<br>1212 Terra Bella Avenue<br>Mountain View, CA 94043-1824 |
|---------------------------|-------------------------------------------------------------------------------|
| Contact Person: | David Buzawa<br>Director of Regulatory Affairs and Quality Assurance |
| Summary Preparation Date: | June 5, 2008 |
| Names | |
| Device Names: | Family of IRIDEX IQ Laser Systems (IQ532, IQ577, IQ... |

Primary Classification Names: Laser Powered Surgical Instruments (and Accessories)

630-670, IQ810) & Delivery Device Accessories

#### III. Predicate Devices

II.

- · IRIS Medical OcuLight TX
- · IRIS Medical IQ 810 Diode Laser
- · IRIS Medical OcuLight GL/GLx
- · Asclepion Meditec AG Laser System Yellow Star
- · Lumenis Novus Varia Ophthalmic Laser
- · IRIDEX OtoProbe
- · IRIDEX D'Amico\Peyman Fluted EndoProbe
- · Straight and Illuminating LaserProbes Adjustable Intuitive
- · IRIDEX IRIS Medical G-Probe Handpieces
- · IRIDEX IRIS Medical DioPexy Probe Handpieces
- · IRIDEX Wireless Footswitch

#### IV. Product Description

The Family of IRIDEX IQ Laser Systems is comprised of the following main components:

- Main console containing the major electrical components, including: .
- A Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display;
- Two delivery device fiber-optic connector ports (only one active at a time); A
- A LIO illumination connection:
- Smart key port for detecting/operating safety filters and/or accessory A identification:
- A Emergency stop switch:
- A Kev switch:
- Connector ports for the footswitch, remote control, and power cord; A

Image /page/0/Picture/28 description: The image shows the text "Page 1 of 5". The text is black and is centered in the image. The text indicates that this is the first page of a five-page document. The text is surrounded by a partial circle.

{1}------------------------------------------------

- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); .
- A Wired Remote Control that duplicates the control panel; .
- Delivery Accessories including OtoProbe handpieces, EndoProbe handpieces, . G-Probe and DioPexy Probe Handpieces, Dermatology Handpieces, Microscope Adapters, and Laser Indirect Ophthalmoscopes.
- . Optional Cart/Stand

#### V. Indications for Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™,or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of , dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

## 532 nm

## Dermatology

- · Pigmented Skin Lesions
- · Vascular Lesions

## Ear. Nose, and Throat (ENT)/ Otolaryngology

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

## Ophthalmology

Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including:

- · Retinal photocoagulation (RPC) for the treatment of
- > Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- > Retinal tears and detachments

{2}------------------------------------------------

- > Lattice degeneration
- > Age-related macular degeneration (AMD)
- > Retinopathy of prematurity
- > Sub-retinal (choroidal) neovascularization
- > Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including > Primary open angle/Closed angle

## 577nm

## Dermatology:

- · Treatment of Vascular and pigmented lesions
## Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

- Retinal photocoagulation, panretinal photocoagulation and intravitreal ● endophotocoagulation of vascular and structural abnormalities of the retina and choroids including :
- > proliferative and nonproliferative diabetic retinopathy;
- > choroidal neovascularization;
- > branch retinal vein occlusion;
- > age-related macular degeneration
- > retinal tears and detachments
- > retinopathy of prematurity
- Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle . Glaucoma

## 630 - 670nm

## Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

- Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- > proliferative and nonproliferative diabetic retinopathy;
- > choroidal neovascularization;
- > branch retinal vein occlusion;
- > age-related macular degeneration
- > retinal tears and detachments
- > retinopathy of prematurity
- Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open . angle glaucoma

{3}------------------------------------------------

## 810nm

## Opthalmology:

photocoagulation, laser laser laser lasser and the best in the best in the best in the best in the best in the best in the best in the best in the best in the been in the best in the been in t trabeculoplasty, transscleral Indicated for retinal cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following:

- Retinal photocoagulation for the treatment of: .
- > Diabetic retinopathy including;
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- > Retinal Tears, Detachments and Holes
- > Lattice degeneration
- > Age-related macular degeneration (AMD) with choroidal neovascularizations (CNV)
- > Retinopathy of prematurity
- > Sub-retinal (choroidal) neovascularization
- > Central and Branch Retinal Vein Occlusion
- Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) . for the treatment of glaucoma, including;
- > Primary open angle
- > Closed angle
- > Refractory Glaucoma (recalcitrant/uncontrolled)

#### VI Performance Standards

The The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]) accessories conforms with: Federal Regulations; the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems: and, International Harmonized Standards.

#### VI. Rationale for Substantial Equivalence

The Family of IRIDEX IQ Laser Systems shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

#### VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Family of IRIDEX IQ Laser Systems is substantially equivalent to the predicate devices.

{4}------------------------------------------------

## VIII. Conclusion

The Family of IRIDEX IQ Laser Systems was found to be substantially equivalent to the predicate devices.

The Family of IRIDEX IQ Laser Systems share the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized feathers and wings.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2008

Iridex Corporation % Mr. David Buzawa Director Regulatory Affairs 1212 Terra Bella Avenue Mountain View, California 94043-1824

Re: K071687

Trade/Device Name: Family of IRIDEX® IQ Laser Systems (1) 532, IQ 577, IQ 630-670, IQ 810) 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: June 8, 2008 Received: June 9, 2008

Dear Mr. Buzawa:

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

{6}------------------------------------------------

Page 2 - Mr. David Buzawa

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. 9

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Mulkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

510(k) Number (if known):

Device Name: Family of IRIDEX® IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810)

K071687

#### Indications for Use:

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]) and the hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of , dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthaimology as follows:

#### 532 nm

#### Dermatology

- · Pigmented Skin Lesions
- · Vascular Lesions

#### Ear, Nose, and Throat (ENT)/ Otolaryngology

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

### Ophthalmology

Indicated for retinal photocoagulation, laser trabeculoplasty, indotomy, indoplasty including:

- · Retinal photocoagulation (RPC) for the treatment of
- > Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- > Retinal tears and detachments
- > Lattice degeneration
- > Age-related macular degeneration (AMD)
- > Retinopathy of prematurity
- > Sub-retinal (choroidal) neovascularization
- > Central and branch retinal vein occlusion
- · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including
- > Primary open angle/Closed angle

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ |
|-------------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General. Restorative. and Neurological Devices

**510(k) Number** K011687

{8}------------------------------------------------

510(k) Number (if known):

Device Name:

Family of IRIDEX® IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810)

#### 577nm

Dermatology:

· Treatment of Vascular and pigmented lesions

#### Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

رK071687

- Retinal photocoagulation, panretinal photocoagulation and intravitreal �
- endophotocoagulation of vascular and structural abnormalities of the retina and choroid including :
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration
- retinal tears and detachments
- retinopathy of prematurity
- � Iridotomy, iridectorny and trabeculoplasty in angle closure glaucoma and open angle Glaucoma

#### 630 - 670nm

�

#### Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

- Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and
- structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration
- retinal tears and detachments
- retinopathy of prematurity
- � Iridotomy, iridectory and trabeculoplasty in angle closure glaucoma and open angle glaucoma

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|--------|------------------------------------------------|
|-------------------------------------------------|--------|------------------------------------------------|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | L 071688 |
|---------------|----------|
|---------------|----------|

{9}------------------------------------------------

Indications for Use Statement - Continued

510(k) Number (if known):

K071687

Family of IRIDEX® IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810) Device Name:

810nm

#### Ophthalmology

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, indotomy, including the following examples:

- · Retinal photocoagulation for the treatment of:
- > Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- > Retinal Tears, Detachments and Holes
- > Lattice degeneration
- > Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- > Retinopathy of prematurity
- > Sub-retinal (choroidal) neovascularization
- > Central and Branch Retinal Vein Occlusion
- Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:
- > Primary open angle
- > Closed angle
- > Refractory Glaucoma (recalcitrant/uncontrolled)

| Prescription Use | AND/OR | Over-The-Counter Use |
|----------------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D)<br>✓ | | (21 CFR 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off

Sign-Off) Division al. Restorative, Division of Gener and Neurological I

510(k) Number K071671