Cleared Traditional

K851408 - SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER

K851408 is an FDA 510(k) clearance for SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, manufactured by Applied Science, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K851408 · Applied Science, Inc. · General & Plastic Surgery device
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Jul 1985
Decision
87d
Days
Class 2
Risk

K851408 is an FDA 510(k) clearance for the SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Applied Science, Inc. (Monrovia, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 87 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.

View all Applied Science, Inc. devices

FDA 510(k) Submission Details - K851408

510(k) Number K851408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date July 05, 1985
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 87
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