Biophotas, Inc.
Tustin, CA, US
BIOPHOTAS, INC. appears in FDA device records in Tustin, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Biophotas, Inc. between 2013 and 2023. The busiest year on record is 2013, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232977 | Biophotas Celluma CONTOUR | OLI | Substantially Equivalent | |
| K211038 | Biophotas Celluma RESTORE | OAP | Substantially Equivalent | |
| K171323 | BIOPHOTAS CELLUMA3 | OHS | Substantially Equivalent | |
| K152280 | BioPhotas Celluma3 | ILY | Substantially Equivalent | |
| K131113 | BIOPHOTAS CELLUMA | ILY | Substantially Equivalent | |
| K122237 | BIOPHOTAS LIFELIGHT | ILY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009765778 | 3009765778 | BIOPHOTAS, INC. | 15501 Red Hill Avenue, Tustin, CA 92780 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain