(74 days)
Not Found
No
The summary describes a laser accessory with a cannula and optical fiber, and explicitly states that mentions of AI, DNN, or ML were "Not Found".
Yes
The device is intended for "laser assisted lipolysis," which is a medical procedure used to treat a condition (excess fat) and improve body contour, thus fitting the definition of a therapeutic device.
No
The device SmoothKit+ is intended for laser assisted lipolysis, which is a therapeutic rather than a diagnostic procedure. Its description as a "medical laser accessory" further supports its role in treatment delivery.
No
The device description clearly states it includes physical components like a cannula, optical fiber, and handpiece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "laser assisted lipolysis." This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "medical laser accessory" including a cannula and optical fiber. This is consistent with a device used for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status based on those samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
SMOOTHKIT+ is intended for laser assisted lipolysis.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
SMOOTHKIT+ is a medical laser accessory. It includes a cannula crimped on an optical fiber and a handpiece. The extremity of the cannula is sharp edges rounded. The extremities of the cannula and of the optical fiber are in the same plan and there is some adhesive between the cannula and the fiber at the distal end.
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)
Performance data demonstrate the safety and effectiveness (mainly biocompatibity) of SMOOTHKIT+ for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KIT LIPO manufactured by OSYRIS, cleared as K073617
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| Trade Name | SMOOTHKIT+ |
|---|---|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | GEX |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketed | KIT LIPO manufactured by OSYRIS, cleared as K073617 |
| predicate devices | |
| 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
SMOOTHKIT+ is a medical laser accessory. It includes a cannula crimped on an optical fiber and a handpiece. The extremity of the cannula is sharp edges rounded. The extremities of the cannula and of the optical fiber are in the same plan and there is some adhesive between the cannula and the fiber at the distal end.
5 - 3. INTENDED USE
SMOOTHKIT+ is intended for laser assisted lipolysis.
5 - 4. PERFORMANCE DATA
Performance data demonstrate the safety and effectiveness (mainly biocompatibity) of SMOOTHKIT+ for its intended use.
5 - 5. SUBSTANTIAL EQUIVALENCE
SMOOTHKIT+ has the same intended use, design and function as predicate devices KIT LIPO manufactured by OSYRIS.
Summary preparation date: July, 10, 2008
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osyris c/o Jaquad Zemmouri 121 Rue Chanzy, BP 90140 Hellemmes, France F59260
Re: K082004 Trade/Device Name: Smoothkit+ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 26, 2008 Received: August 28, 2008
Dear Mr. 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.
2
Page 2 - Jaquad 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 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. Mullen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K0820
Device Name: SMOOTHKIT+
Indications for Use: SMOOTHKIT+ is intended for laser assisted lipolysis.
Prescription Use ✓ Over-The-Counter Use __
AND/OR
(Part 21 CFR 801 Subpart D) (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)
Mark M. Millersen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number