(113 days)
Not Found
No
The description focuses on the laser technology, power supply, and basic electronic controls for parameter setting. There is no mention of AI, ML, or any features that would suggest the use of such technologies.
Yes
The device is intended for laser-assisted lipolysis, which is a medical procedure aimed at treating a medical condition (excess fat) and thus falls under the definition of a therapeutic device.
No
The device is described as a medical laser intended for laser-assisted lipolysis, which is a therapeutic procedure, not a diagnostic one. It emits a laser beam and allows for parameter settings, indicating it performs an active treatment rather than gathering information to determine a condition.
No
The device description clearly outlines significant hardware components including a laser module, optical fiber, power supply, Peltier element, and functional electronics with a touch screen. This is not a software-only device.
Based on the provided information, the SMOOTHLIPO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "laser-assisted lipolysis," which is a procedure performed directly on a patient's body to remove fat. This is an in vivo procedure, not an in vitro diagnostic test.
- Device Description: The description details a medical laser device designed to emit light for a therapeutic purpose (lipolysis). It does not describe a device used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the SMOOTHLIPO is a medical device used for a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
SMOOTHLIPO is intended for laser-assisted lipolysis
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SMQQTHLIPO is the medical laser device using a diode laser module with 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 with the core of 600um. The optical fiber is connected to the laser module via a SMA 905 connector. The SMOOTHLIPO laser includes power supply for the laser (50A, 2V) and a Peltier element built on a ventilated radiator for efficient functioning of the device.
In addition, functional electronics is provided to allow for laser parameter setting and the safe functioning of the device. The adjustments of parameters is achieved through a TFT (touch) 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)
SMOOTHLIPO 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).
SMOOTHLIPO conforms to 21CFR part 1040.10 and 1040.11.
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.
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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MAR 1 7 2009
As required by section 807.92(c)
5 -1 GENERAL INFORMATION
| Trade Name | SMOOTHLIPO™ SYSTEM |
|---|---|
| Classification Name | LASER INSTRUMENT, SURGICAL, POWERED |
| Class | II |
| Product Code | GEX |
| CFR section | 878.4810 |
| Device panel | General & Plastic Surgery |
| Legally marketed | |
| predicate devices | K073617: PHARAON LIPO by OSYRIS INC. |
| Submitter | Elemé Medical, Inc. |
| Heron Cove Office Part | |
| 10 Al Paul Lane, Suite 102 | |
| Merrimack, NH 03054 | |
| Contacts | Michail M. Pankratov, Vice President, Clinical & Regulatory Affairs |
| mpankratov@elememedical.com | |
| Phone: 1-603-816-1645 | |
| Fax: 1-603-662-4762 |
5 -2. DEVICE DESCRIPTION
The SMQQTHLIPO is the medical laser device using a diode laser module with 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 with the core of 600um. The optical fiber is connected to the laser module via a SMA 905 connector. The SMOOTHLIPO laser includes power supply for the laser (50A, 2V) and a Peltier element built on a ventilated radiator for efficient functioning of the device.
In addition, functional electronics is provided to allow for laser parameter setting and the safe functioning of the device. The adjustments of parameters is achieved through a TFT (touch) screen and a tactile flagstone.
5 - 3. INTENDED USE
SMOOTHLIPO is intended for laser-assisted lipolysis
5 - 4. PERFORMANCE DATA
SMOOTHLIPO 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).
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K083476 Pg2 of 2
SMOOTHLIPO conforms to 21CFR part 1040.10 and 1040.11.
5 - 5. SUBSTANTIAL EQUIVALENCE
SMOOTHLIPO has the same intended use, material design and function as predicate device PHARAON LIPO (K073617).
In essence, the SMOOTHLIPO which is manufactured by Osyris is identical to PHARAON LIPO 980 laser from Osyris in its manufacturing, performance, and indications.
Summary preparation date: 11/20/08
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.
MAR 1 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elemé Medical, Inc. % Michail M. Pankratov, MD, PhD VP, Clinical and Regulatory Affairs Heron Cove Office Park 10 Al Paul Lane, Suite 102 Merrimack, New Hampshire 03054
Re: K083478
Trade/Device Name: SMOOTHLIP" System 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 5, 2009 Received: March 6, 2009
Dear Dr. Pankratov:
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
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·Page 2 - Michail M. Pankratov, MD, PhD
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.
for A. in for.
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K08347-8
f
INDICATIONS FOR USE
510(k) Number (if known): KBOWN 194
Device Name: SMOOTHLIPO™ System
Indications for Use: The SMOOTHLIPO is intended for laser-assisted lipolysis
Prescription Use く (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)
Neil R.Oehl forman
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K083478