Surgilase, Inc.
Providence, RI, US
Surgilase, Inc. appears in FDA device records in Providence, RI. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Surgilase, Inc. between 1985 and 1993. The busiest year on record is 1988, with 6. The most recent is 1993, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1988 | 6 |
| 1989 | 4 |
| 1990 | 5 |
| 1991 | 1 |
| 1993 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K932421 | SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE | GEX | Substantially Equivalent | |
| K924664 | SURGILASE FIBERLASE CO2 LASER WAVEGUIDE | GEX | Substantially Equivalent | |
| K905006 | SURGILASE SL 150 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K904203 | SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K902211 | SURGILASE YAG 100 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K900570 | SURGILASE YAG 100 IN ORTHOPEDIC SURGERY | GEX | Substantially Equivalent | |
| K901227 | SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 | GEX | Substantially Equivalent | |
| K901211 | SURGILASE SL50 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K894471 | SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY | GEX | Substantially Equivalent | |
| K894396 | SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER | GEX | Substantially Equivalent | |
| K891461 | SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG | GEX | Substantially Equivalent | |
| K884182 | SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL | GEX | Substantially Equivalent | |
| K884313 | MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS | GEX | Substantially Equivalent | |
| K884311 | MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS | GEX | Substantially Equivalent | |
| K884092 | SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80 | GEX | Substantially Equivalent | |
| K875042 | ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY | LKW | Substantially Equivalent | |
| K881499 | SURGILASE YAG 100 FOR GYNECOLOGY USE | LLO | Substantially Equivalent | |
| K875039 | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | LNK | Substantially Equivalent | |
| K852470 | SURGILASE 40S | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain