Data / Medical devices / United States / Biophotas, Inc.
Biophotas, Inc.: FDA-registered device maker in Tustin, CA, United States, 4 510(k) clearances
Biophotas, Inc. is registered with the FDA (registration 3009765778) in Tustin, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 21, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009765778
- Address
- 15501 Red Hill Avenue #200, Tustin, CA, United States, 92780
- Owner or operator
- BioPhotas (10041655)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 16, 2016
- Registered through
- 2027
- Brand names listed
- Celluma CLEAR, Celluma CONTOUR System, Celluma DELUX, Celluma DELUX CONTOUR, Celluma DELUX XL, Celluma DELUX XL CONTOUR, Celluma ELITE, Celluma FACE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fat Reducing Low Level Laser | OLI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2023 | K232977 | Biophotas Celluma CONTOUR | OLI | Substantially Equivalent | Biophotas, Inc. | accessdata.fda.gov |
| June 29, 2021 | K211038 | Biophotas Celluma RESTORE | OAP | Substantially Equivalent | Biophotas, Inc. | accessdata.fda.gov |
| September 1, 2017 | K171323 | BIOPHOTAS CELLUMA3 | OHS | Substantially Equivalent | Biophotas, Inc. | accessdata.fda.gov |
| March 2, 2016 | K152280 | BioPhotas Celluma3 | ILY | Substantially Equivalent | Biophotas, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Laser, Comb, Hair
- All makers of Fat Reducing Low Level Laser
Updated November 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.