Cleared Traditional

K973865 - BIRTCHER UV LAMP

K973865 is an FDA 510(k) clearance for BIRTCHER UV LAMP, manufactured by Medfaxx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code MXG cleared through the Traditional 510(k) pathway after a 508-day FDA review.

K973865 · Medfaxx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
508d
Days
Class 2
Risk

K973865 is an FDA 510(k) clearance for the BIRTCHER UV LAMP. Classified as Lamp, Uvc, (for Treating Skin And Wounds) (product code MXG), Class II - Special Controls.

Submitted by Medfaxx, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 26, 1999 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Medfaxx, Inc. devices

FDA 510(k) Submission Details - K973865

510(k) Number K973865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date February 26, 1999
Days to Decision 508 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
393d slower than avg
Panel avg: 115d · This submission: 508d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXG Device Classification - Class 2, Special Controls

Product Code MXG Lamp, Uvc, (for Treating Skin And Wounds)
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.