(105 days)
Not Found
No
The device description focuses on the laser technology, power supply, thermal management, and basic electronic controls with a tactile interface for parameter setting. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is intended for "laser assisted lipolysis," which is a medical procedure aimed at breaking down fat cells, indicating a therapeutic purpose.
No
The device is described as being "intended for laser assisted lipolysis," which is a therapeutic procedure rather than a diagnostic one. Its function involves emitting a laser beam for treatment, not gathering information about a patient's condition.
No
The device description explicitly details hardware components such as a laser module, optical fiber, power supply, thermalization system (Peltier element, radiator), electronics, TFT screen, and tactile flagstone. This indicates it is a hardware device with integrated software for control and parameter setting, not a software-only device.
Based on the provided information, the PHARAON LIPO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "laser assisted lipolysis." This is a procedure performed on a living patient's body to remove fat, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a laser system designed to emit light for a therapeutic purpose (lipolysis), not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, such as reagents, sample handling systems, or detection methods for analytes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PHARAON LIPO device's function is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
PHARAON LIPO is intended for laser assisted lipolysis
Product codes
GEX
Device Description
The medical device PHARAON LIPO 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. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fiber of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.
In addition PHARAON LIPO 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
PHARAON LIPO conforms 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 LIPO conforms to 21CFR part 1040.10 and 1040.11.
Performance data demonstrate the safety and effectiveness of PHARAON LIPO 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
510k PHARAON LIPO
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
5 -1 GENERAL INFORMATION
| Trade Name | PHARAON LIPO |
|---|---|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | GEX |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketed | |
| predicate devices | K062321: SMARTLIPO manufactured by CYNOSURE INC. |
| Submitter | OSYRIS |
| 121 Rue Chanzy, BP 90140 | |
| 59260 HELLEMMES FRANCE | |
| Contacts | Pr JAOUAD 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 LIPO 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. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fiber of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.
In addition PHARAON LIPO 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.
5 - 3. INTENDED USE
PHARAON LIPO is intended for laser assisted lipolysis
5 - 4, PERFORMANCE DATA
PHARAON LIPO conforms 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 LIPO conforms to 21CFR part 1040.10 and 1040.11.
Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use.
5 - 5. SUBSTANTIAL EQUIVALENCE
PHARAON LIPO has the same intended use, material design and function as predicate device SMARTLIPO (K062321).
Summary preparation date: December 7, 2007
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2008
Osyris % Pr Jaouad Zemmouri CEO 121, rue Chanzy, BP 90140 59260 Hellemmes France
Re: K073617
Trade/Device Name: Pharaon Lipo Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 26, 2008 Received: March 28, 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
2
Page 2 - Pr Jaouad Zemmouri
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.
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 at (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 N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510k PHARAON LIPO
pg 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): K073617
Device Name: PHARAON LIPO
Indications for Use: PHARAON LIPO is intended for laser assisted lipolysis
Prescription Use 14 (Part 21 CFR 801 Subpart D)
AND/OR
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 Evaluation (ODE)
Nef RPB dl. fs mxn
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K073617