FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE
K Number: K932421
·
Decision Oct 15, 1993
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
19
Review Days
149
Basic Information
- Device Name
- SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE
- K Number
- K932421
- 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
- SURGILASE, INC.
- Date Received
- May 19, 1993
- Decision Date
- October 15, 1993
- 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 SURGILASE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K924664 | SURGILASE FIBERLASE CO2 LASER WAVEGUIDE | Apr 15, 1993 | Substantially Equivalent |
| K905006 | SURGILASE SL 150 SURGICAL LASER SYSTEM | Feb 21, 1991 | Substantially Equivalent |
| K904203 | SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM | Dec 7, 1990 | Substantially Equivalent |
| K902211 | SURGILASE YAG 100 SURGICAL LASER SYSTEM | Jun 29, 1990 | Substantially Equivalent |
| K900570 | SURGILASE YAG 100 IN ORTHOPEDIC SURGERY | May 1, 1990 | Substantially Equivalent |
| K901211 | SURGILASE SL50 SURGICAL LASER SYSTEM | Apr 26, 1990 | Substantially Equivalent |
| K901227 | SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 | Apr 26, 1990 | Substantially Equivalent |
| K894471 | SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY | Nov 14, 1989 | Substantially Equivalent |
| K894396 | SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER | Aug 7, 1989 | Substantially Equivalent |
| K891461 | SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG | Apr 6, 1989 | Substantially Equivalent |