(125 days)
No
The device description focuses on laser technology, thermal regulation, and electronic controls with a tactile screen interface. There is no mention of AI, ML, or related concepts in the provided text. The performance studies reference general laser and software guidance, not AI/ML-specific validation.
Yes
The device is indicated for medical procedures (endovascular coagulation and photocoagulation of teleangectasia) to treat specific conditions (superficial vein reflux and teleangectasia of the legs), which are therapeutic applications.
No
The device is indicated for endovascular coagulation and photocoagulation, which are treatment procedures, not diagnostic ones. Although the EXO application provides "optimal mapping of the treatment area and screen display of the vessel", this is for guiding treatment, not diagnosing a condition.
No
The device description explicitly details hardware components such as a laser module, Peltier element, ventilated radiator, electronics, TFT screen, tactile flagstone, and a handpiece with a cooling system and video. This indicates it is a hardware device with integrated software for control and parameter setting, not a software-only medical device.
Based on the provided information, the PHARAON 980 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses described are for endovascular coagulation and photocoagulation, which are therapeutic procedures performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system designed to deliver energy to tissue. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Anatomical Site: The device is applied to specific anatomical sites (greater saphenous vein, legs) on the patient. IVDs work with samples taken from the patient.
The device is clearly a therapeutic laser system used for medical procedures.
N/A
Intended Use / 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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video
Anatomical Site
greater saphenous vein of the thigh, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data demonstrate the safety and effectiveness of PHARAON ENDO /EXO for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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