Cleared Traditional

K082622 - ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE (FDA 510(k) Clearance)

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

K082622 · Alma Lasers , Ltd. · General & Plastic Surgery device
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Jan 2009
Decision
125d
Days
Class 2
Risk

K082622 is an FDA 510(k) clearance for the ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE. Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by Alma Lasers , Ltd. (Pleasanton, US). The FDA issued a Cleared decision on January 12, 2009 after a review of 125 days - within the typical 510(k) review window.

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.

View all Alma Lasers , Ltd. devices

Submission Details

510(k) Number K082622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2008
Decision Date January 12, 2009
Days to Decision 125 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
11d slower than avg
Panel avg: 114d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUV Massager, Vacuum, Light Induced Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended To Temporarily Alter The Appearance Of Cellulite
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.