Biophysic Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Biophysic Medical, Inc.” (first 1985, latest 1995), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| HQF | Laser, Ophthalmic | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
| LOI | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary | 1 | 1 |
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | 1 | 1 |
Review panels
- Ophthalmic (5)
- Radiology (4)
- General and Plastic Surgery (2)
Most recent Biophysic Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953399 | NEEDLE OR CUTTER | KNW | 1995-10-30 | 102 |
| K893035 | OPHTHASCAN 'S' MINI-A | IYO | 1989-06-12 | 49 |
| K890509 | INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM | HQF | 1989-03-24 | 51 |
| K884595 | OPHTHASCAN MINI-B | IYO | 1989-01-03 | 61 |
| K884456 | STERILE DISPOSABLE ENDOCULAR PROBE | GEX | 1988-12-09 | 46 |
| K883719 | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | LQJ | 1988-10-18 | 48 |
| K881494 | FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER | HQF | 1988-08-30 | 144 |
| K881459 | NANOLAS ND:YAG OPHTHALMIC LASER | LOI | 1988-04-13 | 7 |
| K873460 | OPHTHALAS DYE OPHTHALMIC LASER | HQF | 1987-10-29 | 62 |
| K853116 | PAXIAL | IYO | 1985-10-31 | 98 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biophysic Medical, 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 Biophysic Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Biophysic Medical, Inc.” (first 1985, latest 1995), across 6 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 Biophysic Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biophysic Medical, Inc. is 61 days.
Which FDA product codes appear under Biophysic Medical, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); HQF (Laser, Ophthalmic, 3); GEX (Powered Laser Surgical Instrument, 1).
Next steps
- See all 11 Biophysic Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Biophysic Medical, 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.