Cleared Traditional

K160821 - Tria Sapphire

K160821 is an FDA 510(k) clearance for Tria Sapphire, manufactured by Tria Beauty, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OLP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K160821 · Tria Beauty, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
83d
Days
Class 2
Risk

K160821 is an FDA 510(k) clearance for the Tria Sapphire. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Tria Beauty, Inc. (Dublin, US). The FDA issued a Cleared decision on June 15, 2016 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K160821

510(k) Number K160821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2016
Decision Date June 15, 2016
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLP Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Hogan Lovells US LLP
Jonathan Kahan

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 - OLP Over-the-counter Powered Light Based Laser For Acne

All 50
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