The Family of IR.IDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630mm-670m], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse TM or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dematology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

810nm (IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6 Laser System and Probe Delivery Devices (G-Probe & MicroPulse P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse™ (uP) treatment mode and indicated for the treatment of Glaucoma:

MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: uP

G-Probe: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment: Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

Device Description

The Iridex Cyclo G6 is comprised of the following main components:

Main console containing the major electrical components, including:
- 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);
- LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification:
- Emergency stop switch:
- Key switch;
- Connector ports for the footswitch, remote control, and power cord;
- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust);
- A Wired Remote Control that duplicates the control panel;
- Delivery Accessories including G-Probeand MicroPulse P3 probe Handpieces. Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family).
- Optional Cart/Stand

AI/ML Overview

This document is a 510(k) premarket notification for the Iridex Cyclo G6 laser system. It asserts substantial equivalence to a predicate device (K071687 Family of Iridex IQ Laser Systems), rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of a new diagnostic or AI-based device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of FDA submission.

However, I can extract information related to the device's technical specifications and the basis for its safety and effectiveness claims.

Acceptance Criteria and Reported Device Performance (Table)

Since this is a submission for substantial equivalence based on technological characteristics and indications for use being identical or very similar to a predicate device, specific performance metrics with acceptance criteria as typically seen for novel diagnostic devices are not provided. Instead, the "performance" here relates to the device's physical and functional attributes matching the predicate.

Characteristic	Acceptance Criteria (Predicate's Performance/Specification)	Reported Device Performance (Iridex Cyclo G6)
Indications for Use	Same as K071687	Exactly the same as K071687 (including 810nm Ophthalmology indications for Glaucoma treatment with MicroPulse P3 and G-Probe)
Wavelength	810nm (for the relevant part of the predicate)	810nm
Aiming beam	630nm-650nm	630nm-650nm
Power Watts	≤ 5W	≤ 5W
Pulse Duration (µsec)	10µsec-60min	10µsec-60min
Output Mode	CW (CW-Pulse, MicroPulse, Long Pulse)	CW (CW-Pulse, MicroPulse, Long Pulse)
Repetition rate	≤ 1kHz	≤ 1kHz
Laser media	Diode, Diode-pumped, frequency doubled, solid state	Diode, Diode-pumped, frequency doubled, solid state
User interface	Manual & Remote Controls	Manual & Remote Controls
Laser activation	footswitch	footswitch
Delivery devices, how supplied	Delivery Devices provided Sterile packaged & non-sterile	Delivery Devices provided Sterile packaged & non-sterile
Electrical requirements	90-130 VAC, 50/60 Hz; 200-240 VAC, 50/60 Hz	90-130 VAC, 50/60 Hz; 200-240 VAC, 50/60 Hz

Study Information (Based on the provided document)

Sample size used for the test set and the data provenance:
- Not Applicable. This submission explicitly states: "No clinical data was needed for these indications. They are identical to those on K071687." Therefore, there was no separate "test set" of patient data used to evaluate the device's clinical performance as part of this 510(k). The evaluation relies on the known performance and safety of the predicate device and the new device's comparable technical specifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical data/test set was used for this submission, there was no need for experts to establish ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set was used.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a laser surgical instrument, not an AI-assisted diagnostic or image analysis tool. Therefore, an MRMC study related to human reader improvement with or without AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware laser system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No new clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the existing predicate device, backed by its technical specifications and historical clinical use.
The sample size for the training set:
- Not Applicable. This is a laser hardware system, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary of the Study:

The "study" in this context is a bench testing and engineering comparison against the predicate device, K071687. The submission explicitly states:

"No clinical data was needed for these indications. They are identical to those on K071687."
"The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device."
"The review of the indications for use and technical characteristics provided demonstrates that the Iridex Cyclo G6 Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated."
"The software changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures."

The document relies on the inherent safety and efficacy already established for the predicate device due to the identical indications for use and substantially equivalent technical characteristics of the Iridex Cyclo G6. The "proof" is the detailed comparison of specifications, demonstrating that the new device performs identically to a legally marketed device.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble fabric or water.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 2, 2015

Iridex Corporation c/o Ms. Kathy Maynor Regulatory Consultant 26 Rebecca St. Homosassa, FL 34446

Re: K143154

Trade/Device Name: Iridex Cyclo G6 (with delivery devices) Regulation Number: 21 CFR 878.4810 Regulation Name: Power Laser Surgical Instruments Regulatory Class: Class II Product Code: GEX Dated: December 4, 2014 Received: December 5, 2014

Dear Ms. Maynor:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K143154

Device Name

Family of IR.IDEX® IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, IQ 810[IRIDEX Cyclo G6 Laser System])

Indications for Use (Describe)

810nm (IRIDEX Cyclo G6 Laser System)

Ophthalmology:

	Condition(Indicated for)	Treatment(Intended Use)	CW/μP
MicroPulse P3Device	For the treatment of Glaucomaincluding:• Primary Open-Angle• Closed-Angle• Refractory	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses	μP
G-Probe	For the treatment of Glaucomaincluding:• Primary Open-Angle• Closed-Angle• Refractory	Transscleralcyclophotocoagulation(TSCPC) of the ciliaryprocesses	CW

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

Section 8 – Special 510(k) Summary

I. General Information

Submitter:

Iridex Corporation

Contact Person:

Kathy Maynor

kmaynor77@gmail.com

352-586-3113 (cell)

Summary Preparation Date: October 31, 2014

II. Names

Device Name(s): Cyclo G6

Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories

III. Predicate Devices

K071687 Family of Iridex IQ Laser Systems (IQ 532, IQ 577, IQ 630-670, ● IQ 810)

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

IV. Product Description

The Iridex Cyclo G6 is comprised of the following main components:

Main console containing the major electrical components, including:
- 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);
- LIO illumination connection;
- Smart key port for detecting/operating safety filters and/or accessory identification: ●
- Emergency stop switch:
- Key switch; ●
- Connector ports for the footswitch, remote control, and power cord;
- A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust); ●
- A Wired Remote Control that duplicates the control panel; ●
- Delivery Accessories including G-Probeand MicroPulse P3 probe Handpieces. ● Microscope Adapters, and Laser Indirect Ophthalmoscopes (these are not used with the Cyclo G6 but are available for use with the other members of the laser family).
- Optional Cart/Stand ●

V. Indications for Use

lndications for Use (same as K071687):

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670mm]. IO 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 TM 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 ●

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

Removal of Acoustic Neuromas
. Soft tissue Adhesion in Micro/Macro Otologic Procedures

Ophthalmology

Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including:

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

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 choroid including :
- proliferative and nonproliferative diabetic retinopathy; о
- choroidal neovascularization; O
- branch retinal vein occlusion; O
- age-related macular degeneration O
- O retinal tears and detachments
- retinopathy of prematurity O
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle ● glaucoma

810nm

Ophthalmoloqgy:

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

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

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

No clinical data was needed for these indications. They are identical to those on K071687.

VI. Summary of Technological Characteristics

The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device.

		K071687
Characteristic	Iridex Cyclo G6	Iridex Family of IQ Lasers
Product Code	General & Plastic Surgery	General & Plastic Surgery
Regulation	• GEX, 21 CFR 878.4810	• GEX, 21 CFR 878.4810
Intended Use	Intended for use in dermatology, ear,nose and throat (ENT)/otolaryngology, and ophthalmology	Intended for use indermatology, ear, nose andthroat (ENT)/otolaryngology, andophthalmology
Indications forUse	Exactly the same as K071687	See K071687
Wavelength	810nm	532nm, 577nm, 630-670nm, 810nm
		K071687
Characteristic	Iridex Cyclo G6	Iridex Family of IQ Lasers
Aiming beam	630nm-650nm	630nm-650nm
Power Watts	≤ 5W	≤ 5W
Pulse Duration(usec)	10µsec-60min	10µsec-60min
Output Mode	CW (CW-Pulse, MicroPulse, LongPulse)	CW (CW-Pulse, MicroPulse,Long Pulse)
Repetition rate	≤ 1kHz	≤ 1kHz
Laser media	Diode, Diode-pumped, frequencydoubled, solid state	Diode, Diode-pumped,frequency doubled, solidstate
User interface	Manual & Remote Controls	Manual & Remote Controls
Laseractivation	footswitch	footswitch
Delivery devices, howsupplied	Delivery Devices provided Sterilepackaged & non-sterile	Delivery Devices providedSterile packaged & non-sterile
Electricalrequirements	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz	90-130 VAC, 50/60 Hz200-240 VAC, 50/60 Hz

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

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Iridex Cyclo G6 Laser is substantially equivalent to the predicate device and is safe and effective for use for the various indications for use stated.

The software changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures.

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

VIII. Conclusion

The Iridex G6 Laser was found to be substantially equivalent to the predicate device.

The Iridex G6 Laser shares identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate device.

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.

Re: K143154

Indications for Use

510(k) Number (if known) K143154

Device Name

Indications for Use (Describe)

Ophthalmology:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

I. General Information

II. Names

III. Predicate Devices

IV. Product Description

V. Indications for Use

532 nm

Dermatology

Ear, Nose, and Throat (ENT)/ Otolaryngology

Ophthalmology

577nm

Dermatology:

Ophthalmology:

810nm

Ophthalmoloqgy:

o Laser trabeculoplasty, Iidotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:

No clinical data was needed for these indications. They are identical to those on K071687.

VI. Summary of Technological Characteristics

VII. Safety and Effectiveness Information

VIII. Conclusion

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.