FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DORNIER MEDILAS FIBER TOME LASER
K Number: K964760
·
Decision Feb 19, 1997
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
29
Review Days
84
Basic Information
- Device Name
- DORNIER MEDILAS FIBER TOME LASER
- K Number
- K964760
- 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
- DORNIER MEDTECH AMERICA, INC.
- Date Received
- November 27, 1996
- Decision Date
- February 19, 1997
- 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 DORNIER MEDTECH AMERICA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161771 | Medilas H Laser Fibers | Jul 28, 2016 | Substantially Equivalent |
| K151485 | GENESIS | Jun 30, 2015 | Substantially Equivalent |
| K133434 | GENESIS II | Nov 26, 2014 | Substantially Equivalent |
| K130344 | DORNIER MEDILAS UROPULSE | Mar 21, 2013 | Substantially Equivalent |
| K122159 | DORNIER MEDILAS H30 SOLVO | Feb 1, 2013 | Substantially Equivalent |
| K122768 | GENESIS | Jan 18, 2013 | Substantially Equivalent |
| K123385 | MEDILAS H LASER FIBERS | Dec 14, 2012 | Substantially Equivalent |
| K121656 | GEMINI LITHOTRIPTER | Sep 24, 2012 | Substantially Equivalent |
| K121938 | MEDILAS H RFID LASER FIBER | Aug 1, 2012 | Substantially Equivalent |
| K110364 | DORNIER MEDILAS D LITEBEAM+ 1470 | Dec 7, 2011 | Substantially Equivalent |