Laser Engineering, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Laser Engineering, Inc.” (first 1988, latest 2022), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 53 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 | 1 | 99 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 485 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Laser Engineering, Inc. took a median 485 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 15 | 15 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HHR | Laser, Surgical, Gynecologic | 1 | 1 |
Review panels
Most recent Laser Engineering, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211605 | Dual Switch | GEX | 2022-09-22 | 485 |
| K141908 | DUAL SWITCH | GEX | 2014-10-22 | 99 |
| K924457 | MICROMANIPULATOR | GEX | 1993-05-07 | 247 |
| K912247 | UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY | GCJ | 1991-11-13 | 176 |
| K912347 | BIPURE 1000 | FYD | 1991-09-23 | 118 |
| K910062 | 02-10,001 | GEX | 1991-08-16 | 219 |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | GEX | 1991-06-07 | 42 |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | GEX | 1991-04-22 | 125 |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | HHR | 1988-08-05 | 220 |
| K881588 | MODEL MD-25 LASER FOR SURGICAL USE | GEX | 1988-06-03 | 53 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Laser Engineering, 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.
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 Industries , Ltd. (20 510(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 Engineering, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Laser Engineering, Inc.” (first 1988, latest 2022), across 4 product codes in 3 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 Engineering, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laser Engineering, Inc. is 53 days.
Which FDA product codes appear under Laser Engineering, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 15); FYD (Apparatus, Exhaust, Surgical, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 18 Laser Engineering, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Laser Engineering, 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.