← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K992298 # IRIDERM, MODEL APEX 800 (K992298) _Iridex Corp · GEX · Dec 9, 1999 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K992298 ## Device Facts - **Applicant:** Iridex Corp - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Dec 9, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The IRIDERM Apex 800 is indicated for hair removal. ## Device Story IRIDERM Apex 800 is a semiconductor diode laser system for hair removal. Device delivers pulsed 800 nm infrared laser light; utilizes visible red (630-650 nm) diode laser for aiming. Operator selects pulse duration (5-30 msec) and treatment spot size (7 mm, 8.5 mm, or 10 mm). Energy density varies by spot size (40, 32, 23 J/cm2). Used in clinical settings by healthcare professionals. Laser energy targets hair follicles to achieve hair removal. Benefits include non-invasive hair reduction. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Semiconductor diode laser system; 800 nm infrared output; 630-650 nm red aiming beam. Spot sizes: 7 mm, 8.5 mm, 10 mm. Pulse duration: 5-30 msec. Energy density: 23-40 J/cm2 depending on spot size. Powered surgical laser instrument. ## Regulatory 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 - Cynosure, Inc., PhotoGenica LPIR ([K971737](/device/K971737.md)) - Coherent, Inc., LightSheer ([K973324](/device/K973324.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # K992298 DEC - 9 1999 ## 510(k) Summarv IRIDEX Corporation IRIDERM Apex 800 ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Bradlev J. Renton, Ph.D. IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8100 Contact Person: (same as above) Date Prepared: July 2, 1999 #### Name of Device and Name/Address of Sponsor IRIDERM Apex 800 IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 #### Classification Name Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: 79 GEX #### Predicate Devices The IRIDERM Apex 800 Dermatology Laser System is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324). #### Device Description The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm2 for spot sizes of 7, 8.5 and 10 mm respectively. Visible red (630-650 nm) semiconductor diode lasers are used for aiming. #### Intended Use The IRIDERM Apex 800 is indicated for hair removal. {1}------------------------------------------------ ## Technological Characteristics and Substantial Equivalence The IRIDERM Apex 800 is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324). These predicate devices are indicated for hair removal. The IRIDERM Apex 800 is a semiconductor diode laser system that delivers infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm² for spot sizes of 7, 8.5 and 10 mm respectively. The Cynosure, Inc., PhotoGenica LPIR (K971737) delivers pulsed infrared 755 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 20 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40 and 25 J/cm² for spot sizes of 7 and 10 mm respectively. The Coherent, Inc., LightSheer (K973324) is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into a 9 mm square treatment spot. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is 40 J/cm2. Non-Clinical performance Data: None Clinical performance Data: None ### Conclusion The IRIDERM Apex 800 is substantially equivalent to predicate devices currently legally marketed for the indication of hair removal. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized human figures or birds in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 9 1999 Bradley J. Renton, Ph.D. Vice President, Dermatology IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043 Re: K992298 Trade Name: IRIDERM Apex 800 Regulatory Class: II Product Code: GEX Dated: September 29, 1999 Received: September 30, 1999 Dear Dr. Renton : We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Bradley J. Renton, Ph.D. This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT | 510(k) Number (if known): | Pending K992279 | |---------------------------|-----------------| |---------------------------|-----------------| Device Name: IRIDERM Apex 800 Indications For Use: The IRIDERM Apex 800 is indicated for hair removal. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Pcoellyo (Division Sign-Off) Division of General Restorative Devices K992298 510(k) Number Prescription Use OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K992298](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K992298) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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