FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES
K Number: K903883
·
Decision Sep 19, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
13
Review Days
28
Basic Information
- Device Name
- VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES
- K Number
- K903883
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- METATECH CORP.
- Date Received
- August 22, 1990
- Decision Date
- September 19, 1990
- 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 METATECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K924314 | MOBILE STANDING FRAME | Feb 12, 1993 | Substantially Equivalent |
| K915370 | COPPER VAPOR LASER SYSTEM | Feb 7, 1992 | Substantially Equivalent |
| K890865 | HEXASCAN SCANNER HANDPIECE | Mar 24, 1989 | Substantially Equivalent |
| K883541 | METALASER VASCULASE | Nov 4, 1988 | Substantially Equivalent |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | Oct 27, 1988 | Substantially Equivalent |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Sep 22, 1988 | Substantially Equivalent |
| K882552 | METATECH ROBINSON BOLT ACCESSORY | Sep 8, 1988 | Substantially Equivalent |
| K882367 | METATECH MICROCLIP APPLICATOR | Aug 25, 1988 | Substantially Equivalent |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Jul 18, 1988 | Substantially Equivalent |
| K881447 | METATECH METAL MICROCLIP | Jun 22, 1988 | Substantially Equivalent |