Cleared Traditional

K151400 - Ergoline

K151400 is an FDA 510(k) clearance for Ergoline, manufactured by Jk Holding GmbH. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K151400 · Jk Holding GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
113d
Days
Class 2
Risk

K151400 is an FDA 510(k) clearance for the Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Jk Holding GmbH (Windhagen, DE). The FDA issued a Cleared decision on September 16, 2015 after a review of 113 days - within the typical 510(k) review window.

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

View all Jk Holding GmbH devices

FDA 510(k) Submission Details - K151400

510(k) Number K151400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2015
Decision Date September 16, 2015
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
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 13
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K151400.
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