Laser Industries , Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Laser Industries , Ltd.” (first 1978, latest 1994), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 67 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 | 9 | 9 |
| FDC | Resectoscope, Working Element | 1 | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| HJL | Lens, Condensing, Diagnostic | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Laser Industries , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933362 | SHARPLAN CO2 SURGICAL LASER | GEX | 1994-04-07 | 272 |
| K894765 | SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 | FYD | 1989-09-28 | 64 |
| K850633 | SHARPLAN MODEL 1060 CO/2 SURGICAL LASER | GEX | 1985-08-07 | 169 |
| K850628 | SHARPLAN 1040 CO/2 SURGICAL LASER | GEX | 1985-08-07 | 169 |
| K842997 | LASER RECTOSCOPE SET 784 | FDC | 1984-08-27 | 28 |
| K832550 | SHARPLAN #734 LASER SURGICAL UNIT | GEX | 1984-04-25 | 268 |
| K832551 | SHARPLAN #745 LASER SURG. UNIT | — | 1984-04-23 | 266 |
| K832316 | OPHTHALMIC ARGON LASER #700A | HQF | 1984-01-30 | 199 |
| K837573 | SHARPLAN LASER POSITIONING SYSTEM | — | 1983-06-28 | 32 |
| K837342 | SHARPLAN 721 CO2 SURGICAL LASER | — | 1983-05-18 | 71 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Laser Industries , Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Laser Engineering, Inc. (18 510(k)s)
- Laser Photonics, Inc. (14 510(k)s)
- Laser Media (12 510(k)s)
- Laser Peripherals, LLC (12 510(k)s)
- Laser Spectrum, Inc. (5 510(k)s)
- Laser Max Medical Technologies Corp. (4 510(k)s)
- Laser Optik Systeme GmbH & Co. KG (3 510(k)s)
- Laser Surgical Systems (3 510(k)s)
- Laser Associated Sciences, Inc. (2 510(k)s)
- Laser Center Dev. Corp. (2 510(k)s)
- Laser Dental Innovations (2 510(k)s)
- Laser Endo Technic (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Laser Industries , Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Laser Industries , Ltd.” (first 1978, latest 1994), across 6 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 Laser Industries , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laser Industries , Ltd. is 67 days.
Which FDA product codes appear under Laser Industries , Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9); FDC (Resectoscope, Working Element, 1); FYD (Apparatus, Exhaust, Surgical, 1).
Next steps
- See all 20 Laser Industries , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laser Industries , Ltd.'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.