510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093100Substantially Equivalent

Revlon Rvsp3501 Spa Moisturestay Paraffin Bath (Type Spb3752ea)

Shenzhen Comfort Technology Co., Ltd., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093100 is the FDA 510(k) clearance record for REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA), a class II device, cleared for Shenzhen Comfort Technology Co., Ltd. on under FDA product code IMC (Bath, Paraffin). FDA records list one 510(k) clearance for Shenzhen Comfort Technology Co., Ltd. As of , FDA records show no recalls naming K093100.

Clearance record

Decision date
Received
(54 days to decision)
Product code
IMC Bath, Paraffin
Regulation
21 CFR 890.5110
Device class
Class II
Review panel
Physical Medicine
Applicant
Shenzhen Comfort Technology Co., Ltd. 1705 S. Capital Of Texas Hwy.,, Austin TX
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IMC

Trailing 12 months

FDA records hold no clearances under product code IMC in the trailing twelve months.

FDA records show no clearances under product code IMC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260