Cleared Traditional

K853248 - CHALLENGER SUNRISE

K853248 is an FDA 510(k) clearance for CHALLENGER SUNRISE, manufactured by Challenge Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K853248 · Challenge Products, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
44d
Days
Class 2
Risk

K853248 is an FDA 510(k) clearance for the CHALLENGER SUNRISE. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Challenge Products, Inc. (Lancashire England Bb1 9s, GB). The FDA issued a Cleared decision on September 13, 1985 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 878.4630 - 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 - K853248

510(k) Number K853248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1985
Decision Date September 13, 1985
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.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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 - FTC Light, Ultraviolet, Dermatological

All 273
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K853248.
UVATAN INDUS. UVATAN 900C, 900B/800 & 600C
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ECUMOL ULTRAVIOLET SUNTANNNING BEDS
K853177 · Mottek Intl. Corp. · Aug 1985
TAN MODEL I
K853046 · Philip Munsterman Tan, Inc. · Aug 1985
K853248 · CHALLENGER SUNRISE
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