Cleared Traditional

BIOPHOTAS LIFELIGHT

K122237 · Biophotas, Inc. · Physical Medicine
Jan 2013
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K122237 is an FDA 510(k) clearance for the BIOPHOTAS LIFELIGHT, 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 3, 2013, 161 days after receiving the submission on July 26, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number K122237 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2012
Decision Date January 03, 2013
Days to Decision 161 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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