Submission Details
| 510(k) Number | K152280 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2015 |
| Decision Date | March 02, 2016 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
BioPhotas Celluma3
Mar 2016
Decision
203d
Days
Class 2
Risk
About This 510(k) Submission
K152280 is an FDA 510(k) clearance for the BioPhotas Celluma3, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Biophotas, Inc. (Tustin, US). The FDA issued a Cleared decision on March 2, 2016, 203 days after receiving the submission on August 12, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.
Device Classification
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5500 |
Manufacturer
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