← Product Code [GEX](/productcode/GEX) · K080731 # PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE (K080731) _Osyris · GEX · Jul 17, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K080731 ## Device Facts - **Applicant:** Osyris - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** Jul 17, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs. ## Device Story PHARAON 980 is a surgical laser system emitting coherent light at 970nm ± 10 nm (max 25W). System includes laser module, thermal management via Peltier element/ventilated radiator, and electronic control unit. User interface consists of TFT screen and tactile input. ENDO application performs endovascular coagulation of greater saphenous vein; EXO application performs photocoagulation of leg telangiectasia. EXO configuration utilizes CONTROL4+ handpiece featuring auto-regulated cooling and integrated video for treatment area mapping and vessel visualization on device display. Device intended for clinical use by healthcare professionals. Output allows physician to perform targeted vascular coagulation, potentially benefiting patients by treating superficial vein reflux and telangiectasia. ## Clinical Evidence No clinical data provided. Safety and effectiveness supported by conformance to FDA guidance for medical lasers (June 1995), software submission guidance (May 2005), and 21 CFR 1040.10/1040.11 standards. ## Technological Characteristics Laser surgical instrument; 970nm ± 10 nm wavelength; 25W max power. Thermal management via Peltier element and ventilated radiator. TFT screen/tactile interface. CONTROL4+ handpiece includes auto-regulated cooling and video mapping. Software-controlled parameter settings. Complies with 21 CFR 1040.10 and 1040.11. ## 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 - CERALAS D 980 LASER SYSTEM ([K993911](/device/K993911.md), [K024088](/device/K024088.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}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c) # 5 -1 GENERAL INFORMATION 人080731 | Trade Name | PHARAON 980
ENDO application & EXO application | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name | LASER INSTRUMENT, SURGICAL, POWERED | | Class | II | | Product Code | GEX | | CFR section | 878.4810 | | Device panel | General & Plastic Surgery | | Legally marketed
predicate devices | CERALAS D 980 LASER SYSTEM manufactured by
BIOLITEC numerous 510Ks including K993911 and
K024088 | | Submitter | OSYRIS
121 Rue Chanzy, BP 90140
59260 HELLEMMES FRANCE | | Contacts | Pr JAQUAD ZEMMOURI CEO
jaouad.zemmouri@osyris.com
Phone : +33 (0)3 20 67 59 97
Fax: +33 (0)3 20 04 46 24
Regulatory contact : Dr Isabelle DRUBAIX (Idée
Consulting) idrubaix@nordnet.fr | ## 5 -2. DEVICE DESCRIPTION The medical device PHARAON 980 is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. PHARAON 980 includes the whole of the supplies necessary to supply the laser and to ensure its thermalisation using a Peltier element built on a ventilated radiator. PHARAON 980 includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a TFT screen and a tactile flagstone. PHARAON 980 is available for ENDO application (endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux) and EXO application (photocoagulation of teleangectasia of the legs). PHARAON 980 EXO is supplied with CONTROL4+ HANDPIECE a dedicated handpiece including an auto-requlated cooling system and video allowing optimal mapping of the treatment area and screen display of the vessel on PHARAON 980. ## 5 - 3. INTENDED USE PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs. {1}------------------------------------------------ # 5 - 4. PERFORMANCE DATA PHARAON 980 ENDO & EXO applications conform to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005). PHARAON 980 ENDO & EXO applications conform to 21 CFR part 1040.10 and 1040.11. Performance data demonstrate the safety and effectiveness of PHARAON ENDO /EXO for its intended use. # 5 - 5. SUBSTANTIAL EQUIVALENCE PHARAON 980 ENDO & EXO applications have the same intended use, design and function as predicate devices CERALAS D980 LASER SYSTEM manufactured by BIOLITEC. Summary preparation date: March, 7, 2008 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a bald eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 7 2008 Osyris % Pr Jaouad Zemmouri CEO 121 Rue Chanzy B.P. 90140 Hellemmes, France Re: K080731 Trade/Device Name: PHARAON 980 ENDO & EXO Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in चेन matology Regulatory Class: II Product Code: GEX Dated: June 12, 2008 Received: June 17, 2008 Dear Pr Jaouad Zemmouri: 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 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. {3}------------------------------------------------ Page 2 - Pr Jaouad Zemmouri 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 च्चा (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 M. Millican Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number (if known): A 08073 | Device Name: PHARAON 980 ENDO & EXO Indications for Use: PHARAON 980 ENDO is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. PHARAON 980 EXO is indicated for photocoagulation of teleangectasia of the legs. Prescription Use > AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Eyaluation (ODE) **Division Sta** (Division Sign-Oit) Division of General, Restorative, and Neurological Devices **510(k) Number** 12080731 --- **Source:** [https://fda.innolitics.com/device/K080731](https://fda.innolitics.com/device/K080731) **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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