Coherent Medical Group: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Coherent Medical Group” (first 1985, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 | 21 | 21 |
| HQF | Laser, Ophthalmic | 4 | 4 |
| HQB | Photocoagulator And Accessories | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Review panels
Most recent Coherent Medical Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963339 | COHERENT ULTRAPULSE CO2 SURGICAL LASERS | GEX | 1997-01-22 | 149 |
| K960032 | COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS | GEX | 1996-04-01 | 90 |
| K932981 | COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS | GEX | 1994-05-02 | 318 |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | GEX | 1993-09-29 | 436 |
| K932468 | NOVUS MULTIWAVELENGTH | GEX | 1993-09-22 | 121 |
| K930981 | ACCULITE(TM) OTOPROBE | GEX | 1993-07-28 | 153 |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | GEX | 1992-07-21 | 309 |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | GEX | 1992-05-06 | 181 |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | GEX | 1991-10-08 | 85 |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | GEX | 1991-09-25 | 264 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coherent Medical Group.
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 Division (6 510(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 Group?
FDA lists 27 510(k) clearances under the applicant name “Coherent Medical Group” (first 1985, latest 1997), across 4 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 Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coherent Medical Group is 91 days.
Which FDA product codes appear under Coherent Medical Group?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 21); HQF (Laser, Ophthalmic, 4); HQB (Photocoagulator And Accessories, 1).
Next steps
- See all 27 Coherent Medical Group clearances with predicates and recalls
- Run predicate analysis for product code GEX, Coherent Medical Group'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.