Cleared Traditional

K895409 - REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER

K895409 is an FDA 510(k) clearance for REMINGTON TANFASTIC COUNTERTOP FACIAL T..., manufactured by Remington Products Company, LLC. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K895409 · Remington Products Company, LLC · General & Plastic Surgery device
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Oct 1989
Decision
44d
Days
Class 2
Risk

K895409 is an FDA 510(k) clearance for the REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Remington Products Company, LLC (Bridgeport, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4635 - the FDA general and plastic surgery 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 - K895409

510(k) Number K895409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date October 20, 1989
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEJ Device Classification - Class 2, Special Controls

Product Code LEJ Booth, Sun Tan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LEJ Booth, Sun Tan

All 68
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K895409.
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SHAW SUN SYSTEMS MODEL 1600
K882331 · Shaw Sun Systems · Jun 1988
SUN SHELL (SUN TANNING BED)
K881409 · Indoor Sun Systems, Inc. · Apr 1988
K895409 · REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
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