Cleared Special

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun (K191881) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191881 · Kbl GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
105d
Days
Class 2
Risk

K191881 is an FDA 510(k) clearance for the KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun. Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Kbl GmbH (Dernbach, DE). The FDA issued a Cleared decision on October 28, 2019 after a review of 105 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kbl GmbH devices

Submission Details

510(k) Number K191881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2019
Decision Date October 28, 2019
Days to Decision 105 days
Submission Type Special
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
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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