Cleared Traditional

K881353 - MTI WOLFF SYSTEM

K881353 is an FDA 510(k) clearance for MTI WOLFF SYSTEM, manufactured by Health Systems Intl., Inc.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881353 · Health Systems Intl., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
7d
Days
Class 2
Risk

K881353 is an FDA 510(k) clearance for the MTI WOLFF SYSTEM. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Health Systems Intl., Inc. (Gurnee, US). The FDA issued a Cleared decision on April 6, 1988 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4635 - 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 Health Systems Intl., Inc. devices

FDA 510(k) Submission Details - K881353

510(k) Number K881353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1988
Decision Date April 06, 1988
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LEJ Device Classification - Class 2, Special Controls

Product Code LEJ Booth, Sun Tan
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4635
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 - LEJ Booth, Sun Tan

All 34
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K881353.
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
K151400 · Jk Holding GmbH · Sep 2015
Various Brands of Ultraviolet Lamps
K150778 · Cosmedico Light, Inc. · May 2015
Tanning Lamp
K143043 · Unilam Co., Ltd. · Apr 2015
U.I. OCTOSON
K801675 · Ausonics Pty , Ltd. · Oct 1980
CLINICAL DATA SYSTEM (CAM) MODULE
K801029 · Adac Laboratories · May 1980