Who is the manufacturer of IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

Iridex Corporation filed the 510(k) submission for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate (K162416).

What is the FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

510(k) clearance (submission type: Special).

What are the predicate devices for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

Iridex Cyclo G6 Laser System (K143154).

Who can help prepare an FDA 510(k) submission like IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

K162416 · Iridex Corporation · GEX · Sep 29, 2016 · General, Plastic Surgery

Device Facts

Record ID	K162416
Device Name	IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
Applicant	Iridex Corporation
Product Code	GEX · General, Plastic Surgery
Decision Date	Sep 29, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ 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: 810nm (The IRIDEX Cyclo G6 Laser System) Ophthalmology: The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & 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: [Table data included in source]

Device Story

810nm diode laser system; delivers energy via fiber-optic handpieces (G-Probe, G-Probe Illuminate, MicroPulse P3) in CW-pulse or MicroPulse modes. G-Probe Illuminate incorporates two additional optical fibers for white light transillumination to aid probe placement by visualizing internal ocular structures. Used in ophthalmology clinics by physicians; system console controls power, duration, interval, and mode. Output affects clinical decision-making by enabling targeted coagulation of ciliary processes to treat glaucoma. Benefits include improved probe positioning accuracy via integrated illumination, reducing need for assistants.

Clinical Evidence

No clinical data required. Bench testing only: sterilization (ISO 11135), biocompatibility (ISO 10993-1, -5, -10), light hazard protection (ISO 15004-2), shelf life (ASTM F1980), and transit/packaging testing (ASTM D4169, D4332, F2096, BS EN ISO 11607-1).

Technological Characteristics

810nm infrared diode laser; 5W max power; CW-pulse (10ms-10s) and MicroPulse (10µs-1000µs) modes. Console includes touch screen, knobs, and footswitch activation. G-Probe Illuminate adds 420-700nm white light transillumination. Electrical: 100-240 VAC. Sterile, single-use delivery devices. Sterilization: Ethylene oxide.

Indications for Use

Indicated for patients with glaucoma, including primary open-angle, closed-angle, and refractory glaucoma, requiring transscleral cyclophotocoagulation (TSCPC) of the ciliary processes.

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

Iridex Cyclo G6 Laser System (K143154)

Related Devices

K143154 — IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) · Iridex Corporation · Jan 2, 2015
K032357 — NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES · Lumenis, Inc. · Oct 9, 2003
K202760 — Iridex 810 Laser · Iridex Corporation · Oct 21, 2020
K201502 — Vitra 810 · Quantel Medical · Aug 6, 2020
K213592 — Iridex 810 Laser · Iridex Corporation · Mar 23, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/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 an abstract symbol that resembles three human profiles facing to the right, with a stylized design that suggests flowing hair or water beneath the profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 29, 2016 Iridex Corporation Ms. Kathy Maynor Acting VP of Regulatory/Quality 1212 Terra Bella Avenue Mountain View, CA 94043 Re: K162416 Trade/Device Name: Iridex Cyclo G6 Laser System, G-Probe Illuminate Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: GEX Dated: August 27, 2016 Received: August 30, 2016 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. 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 (reporting of medical device {1}------------------------------------------------ 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" (21 CFR 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, Kesia Alexander 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) K162416 ## Device Name ## Cyclo G6 Laser System with Illumination Indications for Use (Describe) The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ 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: 810nm (The IRIDEX Cyclo G6 Laser System) ## Ophthalmology: The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & 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: | | Condition (Indicated | Treatment (Intended Use) | CW/μP | |---------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------| | MicroPulse P3 Device | For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory | Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes | μP | | G-Probe & G-Probe Illuminate | For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory | Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes | CW | Type of Use (Select one or both, as applicable) [≥] Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 8 - Special 510(k) Summary ### I. General Information Submitter: Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 Contact Person: Kathy Maynor kmaynor@iridex.com 352-586-3113 Summary Preparation Date: September 28, 2016 ### II. Names Device Name(s): Cyclo G6 Laser System with Illumination Primary Classification Name(s): Electrosurgical cutting and coagulation device and accessories ### Predicate Devices III. K143154 -Iridex Cyclo G6 Laser System ### IV. Product Description The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser 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-Probe and MicroPulse P3 probe Handpieces, and the ● G-Probe Illuminate - Optional Cart/Stand {4}------------------------------------------------ The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch. The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings). The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown. The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device. ### V. Indications for Use The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm] [IRIDEX Cyclo G6 Laser System]) 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: 810nm (The IRIDEX Cyclo G6 Laser System) # Ophthalmology: The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe, G-Probe Illuminate, & 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: {5}------------------------------------------------ | | Condition (Indicated for) | Treatment (Intended Use) | CW/μP | |---------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------| | MicroPulse P3 Device | For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory | Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes | μP | | G-Probe & G-Probe Illuminate | For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory | Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes | CW | ### VI. Performance Testing Clinical trial data was not required for this product change. This product change did not require any additional EMC (electromagnetic compatibility) or IEC 60601 safety testing. There were no software changes to the product. The product change did require the following tests, which were successfully completed to the relevant standards: # Sterilization: ISO 11135: 2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices # Biocompatibility: ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for Irritation and Skin Sensitization # Illumination: ISO 15004-2:2007 Ophthalmic Instruments -Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection # Shelf Life: ASTM F1980-07:2011 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices # Transit Testing: ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers {6}------------------------------------------------ and Systems ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packing Components for Testing ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) BS EN ISO 11607-1: 2009 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems {7}------------------------------------------------ ### VII. Summary of Technological Characteristics The technological characteristics of the Iridex Cyclo G6 laser are substantially equivalent to those of the predicate device. | | | K143154 | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Charact eristic | Iridex Cyclo G6 Laser System | Iridex Cyclo G6 Laser System | | Product Code | General & Plastic Surgery | General & Plastic Surgery | | Regulation | • GEX, 21 CFR 878.4810 | • GEX, 21 CFR 878.4810 | | Intended Use | Intended for use for the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory (see section V above) | Intended for use for the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory (see section V above) | | Indications for Use | Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes | Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes | | Wavelength | 810nm - Infrared (IR) Diode | 810nm – Infrared (IR) Diode | | Aiming beam | 630-670 nm – red (nominal) – variable intensity from 0 to < 1.0 mW | 630-670 nm - red (nominal) – variable intensity from 0 to < 1.0 mW | | Power Watts | 5W | 5W | | Pulse Duration (usec) | CW Pulse 10ms-10S MicroPulse (µP) 10µs- 1000µs | CW Pulse 10ms-10S MicroPulse (µP) 10µs-1000µs | | | | K143154 | | Charact eristic | Iridex Cyclo G6 Laser System | Iridex Cyclo G6 Laser System | | Energy per pulse (mJ) | Variable: Determined by Power in Watts and time. Calculated by Joule = Watts x Time | Variable: Determined by Power in Watts and time. Calculated by Joule = Watts x Time | | Output Mode | CW-Pulse, MicroPulse | CW-Pulse, MicroPulse | | Repetitio n rate | <50 Hz | <50 Hz | | Laser media | 810 nm Diode Laser | 810 nm Diode Laser | | Illuminat ion | 420-700 nm | NA | | User interface | Touch Screen, Knobs on Laser Console, Remote Control, Footswitch | Touch Screen, Knobs on Laser Console, Remote Control, Footswitch | | Laser activatio n | Footswitch | Footswitch | | Delivery devices, how supplied | Ordered with System or separately | Ordered with System or separately | | Electrical requirem ents | 100 to 240 VAC @ 50 to 60 Hz | 100 to 240 VAC @ 50 to 60 Hz | {8}------------------------------------------------ {9}------------------------------------------------ # VIII. 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 changes that are the subject of this 510(k) were verified and validated in accordance with the Iridex design control procedures. ### IX. Conclusion The Iridex Cyclo G6 Laser was found to be substantially equivalent to the predicate device. The Iridex Cyclo G6 Laser shares identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate device.