Cleared Traditional

K152233 - BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

K152233 is an FDA 510(k) clearance for BPhase, manufactured by Sportarredo Group S.C.. The device is a Class 2 General & Plastic Surgery device with product code LEJ cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K152233 · Sportarredo Group S.C. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
173d
Days
Class 2
Risk

K152233 is an FDA 510(k) clearance for the BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector.... Classified as Booth, Sun Tan (product code LEJ), Class II - Special Controls.

Submitted by Sportarredo Group S.C. (Gruaro, IT). The FDA issued a Cleared decision on January 27, 2016 after a review of 173 days - an extended review 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: 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.

FDA 510(k) Submission Details - K152233

510(k) Number K152233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date January 27, 2016
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 Consultant

Registrar Corp.
Rhonda Alexander

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LEJ Booth, Sun Tan

All 50
Devices cleared under the same product code (LEJ) and FDA review panel - the closest regulatory comparables to K152233.
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
K152238 · Sun Capsule, Inc. · Mar 2016
3400E series
K151905 · Heartland Tanning, Inc. · Mar 2016
High Pressure Tanning Lamps
K152141 · Blv Licht-Und Vakuumtechnik GmbH · Feb 2016
UV Lamps for Indoor Tanning Devices
K151370 · Light Sources, Inc. · Dec 2015
Suntanning Lamps
K152436 · Interlectric Corporation · Dec 2015
Cosmedico Ultraviolet Lamps of Various Models
K152273 · Cosmedico Light, Inc. · Oct 2015
K152233 · BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Download PDF FDA Summary Sportarredo Group S.C.