Cleared Traditional

K024020 - THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM

K024020 is an FDA 510(k) clearance for THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY..., manufactured by Theralight, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K024020 · Theralight, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
43d
Days
Class 2
Risk

K024020 is an FDA 510(k) clearance for the THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM. Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Theralight, Inc. (Carlsbad, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 43 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 - K024020

510(k) Number K024020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2002
Decision Date January 17, 2003
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
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 183
Devices cleared under the same product code (FTC) and FDA review panel - the closest regulatory comparables to K024020.
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BCLEAR
K021762 · Lumenis, Inc. · Aug 2002
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
K022165 · Theralight, Inc. · Jul 2002
K024020 · THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
Download PDF FDA Summary Theralight, Inc.