Cleared Traditional

K854004 - FLUORESCENT T12 UVA TANNING LAMP

K854004 is an FDA 510(k) clearance for FLUORESCENT T12 UVA TANNING LAMP, manufactured by Light Sources, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K854004 · Light Sources, Inc. · General & Plastic Surgery device
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Oct 1985
Decision
29d
Days
Class 2
Risk

K854004 is an FDA 510(k) clearance for the FLUORESCENT T12 UVA TANNING LAMP. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Light Sources, Inc. (Ansonia, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 29 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 - K854004

510(k) Number K854004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date October 29, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
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 269
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K854004.
GOLDEN RULE SUN TANNING BEDS
K854224 · Golden Rule Tanning Co., Inc. · Nov 1985
I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC
K854171 · Intl. Solarium Manufacturer, Inc. · Nov 1985
SUN TANNING BED
K853846 · Tan America Mfg. · Oct 1985
TOP SUN MODELS 100,101,103 &139, 139-1, 139-3
K853833 · Top Sun America, Inc. · Oct 1985
SUN KING
K853752 · American Chase Company, Inc. · Oct 1985
UV-A SUNTANNING EQUIPMENT
K853911 · Eurotan Intl. · Oct 1985
K854004 · FLUORESCENT T12 UVA TANNING LAMP
Download PDF Light Sources, Inc.