← Product Code [HQF](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF) · K043236 # FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA (K043236) _Quantel Medical · HQF · Feb 7, 2005 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K043236 ## Device Facts - **Applicant:** Quantel Medical - **Product Code:** [HQF](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF.md) - **Decision Date:** Feb 7, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4390 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions: With an indirect ophthalmoscope -- for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments. With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy. With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments. ## Device Story Quantel Vitra Ophthalmic Laser Photocoagulator is a frequency-doubled Nd:YAG laser (532 nm) utilizing a KTP crystal. Device delivers coherent light energy to ocular tissue via delivery systems including indirect ophthalmoscopes, endocular probes, or slit lamps. Operated by ophthalmologists in clinical settings to perform retinal photocoagulation. Laser energy creates thermal effects on retinal tissue to treat conditions like diabetic retinopathy and retinal detachments. Output is controlled by the clinician to achieve therapeutic photocoagulation, aiding in the management of retinal pathologies and preventing vision loss. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Nd:YAG laser with KTP crystal; 532 nm wavelength; coherent light output. Delivery via indirect ophthalmoscope, endocular probe, or slit lamp. Class II device (21 CFR 886.4390). ## Regulatory Identification An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. ## Predicate Devices - B.V.I. Viridis Laser ([K960867](/device/K960867.md)) - Novus Verdi Laser and Delivery Systems ([K991258](/device/K991258.md)) - Carl Zeiss Visulas 532s ([K013402](/device/K013402.md)) - Quantel Viridis Twin Laser ([K023464](/device/K023464.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}------------------------------------------------ # FEB - 7 2005 ## 510(k) SUMMAR Y # KO 43236 This 510(k) summary of safety and effectiveness for the modification in the Indications for Use for the Vitra Ophthalmic Laser Photocoagulator is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary. | Applicant: | Quantel Medical | |-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | QUANTEL MEDICAL
21 rue Newton
Z.I. du Br 'zet
63039 Clermont-Ferrand
Cedex 2
FRANCE
+33 (0)473 745 745
+33 (0)473 745 700 (Fax) | | Contact Person: | Mr. Jean Abascal
Regulatory Affairs Manager

(+33) 169 29 17 25
(+33) 169 29 17 29 | Preparation Date: November 2004 (of the Summary) Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator - Common Name: Ophthalmic Laser, frequency doubled Nd: YAG (532 nm) laser Laser Surgical Instrument, frequency doubled Nd: Y AG (532 nm) laser Ophthalmic laser (see 21 CFR 886.4390) Classification Product Code: HQF; Panel: 86 Name: - Predicate devices: B.V.I. Viridis Laser (K960867); Novus Verdi Laser and Delivery Systems (K991258), Carl Zeiss Visulas 532s (K013402), and the 532 nm laser of the Quantel Viridis Twin Laser (K023464). - Device description: The Quantel Vitra Ophthalmic Laser Photocoagulator is a Nd:YAG frequency doubled laser with a KTP crystal which emits a beam of coherent light at 532 nm. The energy is delivered to the treatment site(s) via delivery systems/devices. {1}------------------------------------------------ - Indications: The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions: With an indirect ophthalmoscope - for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments. With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy. With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments. Performance Data: None required. - CONCLUSION: Based on the information in this notification Quantel Medical concludes that the Vitra Ophthalmic Laser Photocoagulator is substantially equivalent to the cited legally marketed predicates. Information regarding delivery systems which may be used with the laser is supplied by Quantel Medical; the individual devices or systems are marketed by their respective manufacturers who have the responsibility for complying with applicable regulations and marketing requirements. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 7 2005 Quantel Medical c/o Mr Roger Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913 Re: K043236 Ko+5230 Trade/Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF Dated: November 19, 2004 Received: November 22, 2004 #### Dear Mr. Barnes: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regary the enactment date of the Medical Device Amendments, or to comments provided in accordance with the provisions of the Federal Food. Drug. devices may been receissined in assee approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The I ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of tax tice, 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 If your device is elassinod (600 as controls. Existing major regulations affecting your device can may oc subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be fourther announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr o locan that your device complies with other requirements of the Act that I DA has made a determissions administered by other Federal agencies. You must of any I cacal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 – Mr Roger Barnes This letter will allow you to begin marketing your device as described in your Section 510(k) 10 1legal This letter will allow you to begin maketing your active of your device of your device to a legally premarket notification. The FDA midnig of substantal equive 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 rs the results of the may of 10, 276 0115. All as a loca note the requilati If you desire specific advice for your ac vice on our nooming the regulation entitled, contact the Office of Compliance at (240) 276-0115. Also, please note the regulation o contact the Office of Colliphalice at (240) 270 - 131 (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket notification" (21CFR Part 807.97). "Misbranding by reference to premarket nonfication" (1733 Act from the Division of Small other general information on your responsibilities under the Act from the (800) 638-2 other general information on your responsionner Assistance at is toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at is toll-free which Manufacturers, Internet address http://www.fda.cov/cdrb/industry/support/index.html. Sincerely yours, Mark A. Milliken Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### INDICATIONS FOR USE STATEMENT # 510(k) Number (if known): _ K043236 Device Name: Quantel Vitra Ophthalmic Laser Photocoagulator Indications for Use Statement: The Vitra Ophthalmic Laser Photocoagulator is indicated for retinal photocoagulation in the following conditions: With an indirect ophthalmoscope -- for peripheral photocoagulation for the treatment of proliferative diabetic retinopathy and retinal detachments. With an endocular probe – for intraocular retinal photocoagulation as an adjunct to vitrectomy surgery (and not the sole indication for vitrectomy) in the management of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy. With a slit Lamp - for the treatment of proliferative diabetic retinopathy, choroidal neovascularization secondary to age-related macular degeneration, and retinal detachments. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation Prescription Use X (Per 21 CFR 801.109) OR - Over-The Counter Use (Division Sign-Off) Division of General, Restorative, and Necrological Devices 036 510(k) Number K04 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K043236](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQF/K043236) **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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