Laser Assisted Lipolysis
The Laser Assisted Lipolysis device (product code ORK) is a surgical instrument used to perform laser-assisted lipolysis, a minimally invasive procedure that uses laser energy to liquefy and remove subcutaneous fat tissue. It is used in aesthetic and reconstructive surgical procedures. As an FDA Class 2 device under regulation 878.4810, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- ORK
- Device Class
- FDA class 2
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Intended to be used for laser assisted lipolysis
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K090754 | LIPOCONTROL | Jan 21, 2011 | Substantially Equivalent | Osyris Medical |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.