Cleared Traditional

K022626 - MOISTURESTAY (REVLON)

K022626 is an FDA 510(k) clearance for MOISTURESTAY (REVLON), manufactured by Raymond Industrial, Ltd.. The device is a Class 2 Physical Medicine device with product code IMC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K022626 · Raymond Industrial, Ltd. · Physical Medicine device
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Oct 2002
Decision
83d
Days
Class 2
Risk

K022626 is an FDA 510(k) clearance for the MOISTURESTAY (REVLON). Classified as Bath, Paraffin (product code IMC), Class II - Special Controls.

Submitted by Raymond Industrial, Ltd. (Saint Petersburg, US). The FDA issued a Cleared decision on October 29, 2002 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5110 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022626

510(k) Number K022626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2002
Decision Date October 29, 2002
Days to Decision 83 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 116d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMC Device Classification - Class 2, Special Controls

Product Code IMC Bath, Paraffin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IMC Bath, Paraffin

All 10
Devices cleared under the same product code (IMC) and FDA review panel - the closest regulatory comparables to K022626.
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
K093100 · Shenzhen Comfort Technology Co., Ltd. · Nov 2009
SOFTIQUE, MODEL GI 11001
K013707 · Global TV Concepts, Ltd. · Feb 2002
REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
K013328 · Remington Products Company, LLC · Dec 2001
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
K001860 · Homedics, Inc. · Aug 2000
PARAMED PARAFFIN WARMER
K991427 · Divi Intl. Co. · Aug 1999
PARA-CARE
K980718 · Chattanooga Group, Inc. · Mar 1998
K022626 · MOISTURESTAY (REVLON)
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