FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER
K Number: K944627
·
Decision Nov 3, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
22
Review Days
44
Basic Information
- Device Name
- MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER
- K Number
- K944627
- 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 3, 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 |
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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 |
| K944621 | MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |
| K944624 | MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |
| K944623 | MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |