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 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
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

810nm
Opthalmology:
Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral 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)

Device 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
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

AI/ML Overview

The provided 510(k) summary for the Family of IRIDEX IQ Laser Systems (K071687) does not contain information related to acceptance criteria or a study demonstrating the device meets such criteria.

This document is a premarket notification for substantial equivalence, which primarily focuses on arguing that a new device is as safe and effective as a legally marketed predicate device. In such submissions, the manufacturer typically references existing performance standards and demonstrates that their device conforms to these rather than presenting a performance study with specific acceptance criteria.

The summary states:

Performance Standards: "The Family of IRIDEX® IQ Laser Systems ... conforms with: Federal Regulations; the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems: and, International Harmonized Standards." (Page 3)
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." (Page 3)
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." (Page 3)

These statements indicate that the device's conformity is established by adherence to existing regulations and standards, and by demonstrating similarity to previously cleared devices. There is no mention of a specific study conducted by IRIDEX Corporation with defined acceptance criteria to "prove" device performance in the way one might expect for a novel or significantly different device requiring clinical data.

Therefore, I cannot populate the requested table and answer the specific questions below, as the information is not present in the provided text. The document is a regulatory submission focused on substantial equivalence rather than a detailed report of a performance study with acceptance criteria.

Summary

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

Section 1-510(k) Summary Statement K071687

AUG - 7 2008

I. General Information

Submitter:	IRIDEX Corporation1212 Terra Bella AvenueMountain View, CA 94043-1824
Contact Person:	David BuzawaDirector 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 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(Part 21 CFR 801 Subpart D)	✓
AND/OR
Over-The-Counter Use(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(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(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)✓		(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

Regulation Number and Section

§ 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.