Cleared Traditional

K172555 - SAPPHIRE, ELEVARE SAPPHIRE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172555 · Omm Imports, Inc. D/B/A Zero Gravity · General & Plastic Surgery device
May 2018
Decision
250d
Days
Class 2
Risk

K172555 is an FDA 510(k) clearance for the SAPPHIRE, ELEVARE SAPPHIRE. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Omm Imports, Inc. D/B/A Zero Gravity (Doral, US). The FDA issued a Cleared decision on May 1, 2018 after a review of 250 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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.

Submission Details

510(k) Number K172555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2017
Decision Date May 01, 2018
Days to Decision 250 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 132d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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.