FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DORNIER SCANNER HANDPIECE
K Number: K993146
·
Decision Nov 8, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
49
Basic Information
- Device Name
- DORNIER SCANNER HANDPIECE
- K Number
- K993146
- 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 SURGICAL PRODUCTS, INC.
- Date Received
- September 20, 1999
- Decision Date
- November 8, 1999
- 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 SURGICAL PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K003993 | DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) | Mar 26, 2001 | Substantially Equivalent |
| K000072 | DORNIER MEDILAS D SKINPULSE | Jun 12, 2000 | Substantially Equivalent |
| K001243 | DORNIER MEDILAS H | May 24, 2000 | Substantially Equivalent |
| K991183 | DORNIER LASERTRODE FIBER | Jun 9, 1999 | Substantially Equivalent |
| K984591 | DORNIER MEDILAS H/2 | Mar 26, 1999 | Substantially Equivalent |
| K982629 | DORNIER MEDILAS D | Sep 14, 1998 | Substantially Equivalent |
| K981438 | DORNIER MEDILAS E | Jul 20, 1998 | Substantially Equivalent |
| K981718 | DORNIER MEDILAS H | Jul 17, 1998 | Substantially Equivalent |