Cleared Traditional

REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)

K093100 · Shenzhen Comfort Technology Co., Ltd. · Physical Medicine

Nov 2009

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K093100 is an FDA 510(k) clearance for the REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA), a Bath, Paraffin (Class II — Special Controls, product code IMC), submitted by Shenzhen Comfort Technology Co., Ltd. (Austin, US). The FDA issued a Cleared decision on November 24, 2009, 54 days after receiving the submission on October 1, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5110.

Submission Details

510(k) Number	K093100 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2009
Decision Date	November 24, 2009
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF