Cleared Traditional

BIOPHOTAS CELLUMA

K131113 · Biophotas, Inc. · Physical Medicine
Jan 2014
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K131113 is an FDA 510(k) clearance for the BIOPHOTAS CELLUMA, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Biophotas, Inc. (Laguna Nuguel, US). The FDA issued a Cleared decision on January 15, 2014, 268 days after receiving the submission on April 22, 2013. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number K131113 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2013
Decision Date January 15, 2014
Days to Decision 268 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ILY — Lamp, Infrared, Therapeutic Heating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5500

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