Cleared Traditional

K842787 - SUNBED

K842787 is an FDA 510(k) clearance for SUNBED, manufactured by Sun Health Systems. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K842787 · Sun Health Systems · General & Plastic Surgery device
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Aug 1984
Decision
27d
Days
Class 2
Risk

K842787 is an FDA 510(k) clearance for the SUNBED. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Sun Health Systems (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 27 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 - K842787

510(k) Number K842787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1984
Decision Date August 15, 1984
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 223
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K842787.
MTI 1200, 401 & 3500
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EMUMOL ULTRAVIOLET SUNTANNING LAMP
K843814 · Mottek Intl. Corp. · Oct 1984
BROWNIE BOOTH BB1
K842975 · Weingart, Inc. · Aug 1984
ULTRA-VIOLET A SOURCE LIGHT EMITTING
K842575 · Sola-Tan Intl. · Aug 1984
ULTRA-VIOLET EMITTING SUNLAMP PRODUCT
K842384 · Sola-Tan Intl. · Aug 1984
SUN BEDS
K841614 · Sunworld Corp. · May 1984
K842787 · SUNBED
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