Cleared Traditional

K803264 - SUNLAMP

K803264 is an FDA 510(k) clearance for SUNLAMP, manufactured by Am Labs, Inc.. The device is a Class 2 Radiology device with product code FTC cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K803264 · Am Labs, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
160d
Days
Class 2
Risk

K803264 is an FDA 510(k) clearance for the SUNLAMP. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Am Labs, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 160 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4630 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Am Labs, Inc. devices

FDA 510(k) Submission Details - K803264

510(k) Number K803264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1980
Decision Date June 02, 1981
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
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 Radiology devices follow this clearance model.

Regulatory Peers - FTC Light, Ultraviolet, Dermatological

All 83
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K803264.
HAND/FOOT UVA 624-218
K872605 · National Biological Corp. · Jul 1987
MAXI-TAN DEVICE
K864546 · National Biological Corp. · Jan 1987
FOLDALITE UNIT
K827890 · National Biological Corp. · Aug 1982
HOUVA-LITE ARM UNIT #601
K761186 · National Biological Corp. · Feb 1977
HOUVA-LITE LEG UNIT #701
K761187 · National Biological Corp. · Feb 1977
HOUVA-LITE PALM UNIT #501
K761188 · National Biological Corp. · Feb 1977