Cleared Traditional

Apollo Duet (Model : APD-4000) (K212253) - FDA 510(k) Clearance

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

K212253 · Weero Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
402d
Days
Class 2
Risk

K212253 is an FDA 510(k) clearance for the Apollo Duet (Model : APD-4000). Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Weero Co. (Suwon-Si, KR). The FDA issued a Cleared decision on August 25, 2022 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Weero Co. devices

Submission Details

510(k) Number K212253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2021
Decision Date August 25, 2022
Days to Decision 402 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
287d slower than avg
Panel avg: 115d · This submission: 402d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In 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.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 56
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K212253.
C.C. LIFE 21
K213295 · 21 Equipment S.R.L. · Nov 2022
Back 3 COLOR
K214090 · Swims America Corp · Nov 2022
Palm NRG cellulite body device (model: Palm NRG body device)
K214015 · Heat IN A Click, LLC · Sep 2022
Diacare 7000
K211207 · Globus Sport and Health Technologies, LLC · Jun 2022
Venus BlissMAX
K220592 · Venus Concept USA, Inc. · Apr 2022
Venus BlissMAX
K213308 · Venus Concept USA, Inc. · Jan 2022