Lca, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Lca, Inc.” (first 1990, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 133 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 | 10 | 10 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Lca, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952792 | PADLESS ELECTROSURGICAL PENCIL | GEI | 1995-08-28 | 70 |
| K944091 | THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS | GEX | 1994-10-07 | 46 |
| K935439 | SNJ SMOKE EVACUATION SUCTION WAND | FYD | 1994-03-07 | 115 |
| K935258 | HYBRID SURGICAL DEVICE MODIFICATION | GEX | 1994-01-13 | 73 |
| K925726 | ALLOY SCALPEL HANDPIECES, MODIFICATION | GEX | 1993-11-22 | 374 |
| K931070 | CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM | GEX | 1993-10-05 | 217 |
| K924160 | HYBRID SURGICAL DEVICE | GEX | 1993-04-23 | 247 |
| K923991 | ZOE LASER, CONTACT ND:YAG LASER SYSTEM | GEX | 1993-03-31 | 233 |
| K924120 | MOLDED FIBER CAP DELIVERY SYSTEM | GEX | 1993-03-19 | 217 |
| K901365 | LASER FORCEPS HANDPIECE | GEX | 1990-08-21 | 151 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lca, 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 Lca, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Lca, Inc.” (first 1990, latest 1995), across 3 product codes in 2 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 Lca, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lca, Inc. is 133 days.
Which FDA product codes appear under Lca, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 10); FYD (Apparatus, Exhaust, Surgical, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 12 Lca, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Lca, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.