Biophotas, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biophotas, Inc.” (first 2013, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 140 days. Since 2017 the median was 83 days, against 90 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 161 |
| 2014 | 1 | 268 |
| 2015 | 0 | — |
| 2016 | 1 | 203 |
| 2017 | 1 | 119 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 83 |
| 2022 | 0 | — |
| 2023 | 1 | 61 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biophotas, Inc. took a median 83 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | 3 | 3 |
| OAP | Laser, Comb, Hair | 1 | 1 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
| OLI | Fat Reducing Low Level Laser | 1 | 1 |
Review panels
Most recent Biophotas, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232977 | Biophotas Celluma CONTOUR | OLI | 2023-11-21 | 61 |
| K211038 | Biophotas Celluma RESTORE | OAP | 2021-06-29 | 83 |
| K171323 | BIOPHOTAS CELLUMA3 | OHS | 2017-09-01 | 119 |
| K152280 | BioPhotas Celluma3 | ILY | 2016-03-02 | 203 |
| K131113 | BIOPHOTAS CELLUMA | ILY | 2014-01-15 | 268 |
| K122237 | BIOPHOTAS LIFELIGHT | ILY | 2013-01-03 | 161 |
Recalls
openFDA lists no recalls under a recalling firm named Biophotas, 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 Biophotas, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Biophotas, Inc.” (first 2013, latest 2023), 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 Biophotas, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biophotas, Inc. is 140 days. Since 2017: 83 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biophotas, Inc.?
The most frequent FDA product codes under this applicant name are ILY (Lamp, Infrared, Therapeutic Heating, 3); OAP (Laser, Comb, Hair, 1); OHS (Light Based Over The Counter Wrinkle Reduction, 1).
Next steps
- See all 6 Biophotas, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILY, Biophotas, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.