FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 120-SC LASER DELIVERY PROBE
K Number: K944631
·
Decision Nov 1, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
22
Review Days
42
Basic Information
- Device Name
- MODEL 120-SC LASER DELIVERY PROBE
- K Number
- K944631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MNLASE, INC.
- Date Received
- September 20, 1994
- Decision Date
- November 1, 1994
- 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 MNLASE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K944630 | MODEL 230-SAS LASER DELIVERY PROBE | Nov 9, 1994 | Substantially Equivalent |
| K944628 | MODEL 220-SS LASER DELIVERY PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944625 | MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 3, 1994 | Substantially Equivalent |
| K944626 | MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 3, 1994 | Substantially Equivalent |
| K944471 | STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944629 | MODEL 230-SAC LASER DELIVERY PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944470 | CURVED ENDOPHOTOCOAGULATOR LASER PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944627 | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER | Nov 3, 1994 | Substantially Equivalent |
| K944621 | MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |
| K944624 | MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |