Coherent Medical Division: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Coherent Medical Division” (first 1979, latest 1990), plus 1 PMA decision, across 6 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 | 2 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| HKO | Refractometer, Ophthalmic | 1 | 1 |
| HPJ | Instrument, Visual Field, Laser | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 0 |
Review panels
Most recent Coherent Medical Division 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902990 | COHERENT HOLMIUM:YAG SURGICAL LASER | GEX | 1990-10-02 | 85 |
| K822908 | COHERENT FUNDUSL RETINAL CAMERA | HKI | 1983-01-05 | 97 |
| K822415 | THE OCUPLOT D | HPJ | 1982-09-07 | 27 |
| K801906 | DIOPTRON III AUTOREFRACTOR | HKO | 1980-08-27 | 16 |
| K801336 | MODEL 900K PHOTOCOAGULATOR | HQF | 1980-07-28 | 54 |
| K791895 | ACCESSORIES FOR SYS. 400 CO2 SURG. LASER | GEX | 1979-12-20 | 86 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P830054 | PMA | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | 1984-07-02 |
Recalls
openFDA lists no recalls under a recalling firm named Coherent Medical Division.
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.
- Coherent Medical Group (27 510(k)s)
- Coherent Radiation Laboratories (3 510(k)s)
- Coherent Systems, Inc. (3 510(k)s)
- Coherent Medical Lasers (2 510(k)s)
- Coherent Star (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coherent Medical Division?
FDA lists 6 510(k) clearances under the applicant name “Coherent Medical Division” (first 1979, latest 1990), plus 1 PMA decision, across 6 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 Coherent Medical Division?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coherent Medical Division is 70 days.
Which FDA product codes appear under Coherent Medical Division?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 2); HKI (Camera, Ophthalmic, Ac-Powered, 1); HKO (Refractometer, Ophthalmic, 1).
Next steps
- See all 6 Coherent Medical Division clearances with predicates and recalls
- Run predicate analysis for product code GEX, Coherent Medical Division'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.