Surgilase, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Surgilase, Inc.” (first 1985, latest 1993), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 16 | 16 |
| LKW | Laser, Neurosurgical | 1 | 1 |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 1 | 1 |
| LNK | Laser For Gastro-Urology Use | 1 | 1 |
Review panels
Most recent Surgilase, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932421 | SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE | GEX | 1993-10-15 | 149 |
| K924664 | SURGILASE FIBERLASE CO2 LASER WAVEGUIDE | GEX | 1993-04-15 | 226 |
| K905006 | SURGILASE SL 150 SURGICAL LASER SYSTEM | GEX | 1991-02-21 | 107 |
| K904203 | SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM | GEX | 1990-12-07 | 86 |
| K902211 | SURGILASE YAG 100 SURGICAL LASER SYSTEM | GEX | 1990-06-29 | 50 |
| K900570 | SURGILASE YAG 100 IN ORTHOPEDIC SURGERY | GEX | 1990-05-01 | 83 |
| K901227 | SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120 | GEX | 1990-04-26 | 43 |
| K901211 | SURGILASE SL50 SURGICAL LASER SYSTEM | GEX | 1990-04-26 | 43 |
| K894471 | SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY | GEX | 1989-11-14 | 119 |
| K894396 | SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER | GEX | 1989-08-07 | 21 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgilase, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgilase, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Surgilase, Inc.” (first 1985, latest 1993), across 4 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Surgilase, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgilase, Inc. is 83 days.
Which FDA product codes appear under Surgilase, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 16); LKW (Laser, Neurosurgical, 1); LLO (Laser, Neodymium:Yag, Pulmonary Surgery, 1).
Next steps
- See all 19 Surgilase, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Surgilase, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.