FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ELIPO
K Number: K073715
·
Decision Apr 23, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
29
Review Days
114
Basic Information
- Device Name
- ELIPO
- K Number
- K073715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYNERON MEDICAL LTD.
- Date Received
- December 31, 2007
- Decision Date
- April 23, 2008
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by SYNERON MEDICAL LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K151655 | CO2RE System | Sep 15, 2015 | Substantially Equivalent |
| K141507 | TWO SKIN TREATMENT SYSTEM | Dec 8, 2014 | Substantially Equivalent |
| K141708 | ULTRASHAPE SYSTEM | Oct 6, 2014 | Substantially Equivalent |
| K120510 | TRANSCEND | Jul 19, 2013 | Substantially Equivalent |
| K121598 | ME HAIR2GO | Oct 12, 2012 | Substantially Equivalent |
| K122579 | VELASHAPE | Sep 13, 2012 | Substantially Equivalent |
| K101321 | EMATRIX CO2 | Nov 9, 2010 | Substantially Equivalent |
| K090025 | MATRIX RF APPLICATOR | Jan 8, 2010 | Substantially Equivalent |
| K073572 | MATRIX RF APPLICATOR | Sep 17, 2008 | Substantially Equivalent |
| K071872 | VELASHAPE | Aug 22, 2007 | Substantially Equivalent |