Cleared Traditional

ELECTRO-LIGHT THERAPY

K090250 · Hill Laboratories Co. · Physical Medicine
Feb 2010
Decision
374d
Days
Class 2
Risk

About This 510(k) Submission

K090250 is an FDA 510(k) clearance for the ELECTRO-LIGHT THERAPY, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Hill Laboratories Co. (Frazer, US). The FDA issued a Cleared decision on February 11, 2010, 374 days after receiving the submission on February 2, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number K090250 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2009
Decision Date February 11, 2010
Days to Decision 374 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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