Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NFO — Predicate Candidate Screening
79 FDA 510(k) clearances under this product code; the 50 most recent screened below.
172 daysmedian FDA review time
437 days90th percentile
79clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-07-23 | 226 | 0 |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 2026-06-03 | 133 | 0 |
| K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | 2026-05-28 | 71 | 0 |
| K252621 | DeepSkin (DEP100) | El Global Trade, Ltd. | 2026-05-08 | 262 | 0 |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SK | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025-12-23 | 167 | 0 |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 2025-12-23 | 162 | 0 |
| K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | 2025-10-29 | 243 | 0 |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) | Shenzhen Qianyu Technology Co., Ltd. | 2025-10-17 | 263 | 0 |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radian | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025-10-12 | 192 | 0 |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2025-10-09 | 57 | 0 |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | 2025-09-18 | 112 | 0 |
| K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | A-1 Engineering | 2025-09-03 | 75 | 0 |
| K252218 | MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. | 2025-07-18 | 3 | 0 |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co., Ltd. | 2025-07-10 | 196 | 0 |
| K250361 | SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech GmbH | 2025-05-23 | 102 | 0 |
| K243072 | Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. | 2025-04-01 | 186 | 0 |
| K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025-03-06 | 106 | 0 |
| K243063 | Myolight Microcurrent Handpiece | Raja Trading Company, Inc. | 2025-02-10 | 136 | 0 |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-02-03 | 95 | 0 |
| K244048 | Medi Lift Mask | Ya-Man, Ltd. | 2025-01-16 | 16 | 0 |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812 | Shenzhen Aozemei Technology Co., Ltd. | 2024-12-19 | 44 | 0 |
| K242532 | BTL-785BNF-E | BTL Industries, Inc. | 2024-12-13 | 109 | 0 |
| K240564 | NuFACE® FIX+ | Carol Cole Company Dba Nuface® | 2024-06-27 | 119 | 0 |
| K232242 | BEAR 2 Body | Foreo, Inc. | 2024-05-13 | 290 | 0 |
| K233667 | Facial Toning device (UIC-189); Facial Toning device (UIC-58 | Body Trim Industrial Co., Ltd. | 2024-02-12 | 89 | 0 |
| K233525 | MF SC Facial Toning System | Micro Current Technology, Inc. | 2023-11-24 | 23 | 0 |
| K232001 | Nu Skin RenuSpa iO | Nse Products, Inc. | 2023-11-21 | 139 | 0 |
| K233010 | Beagank 4T Plus | Belega, Inc. | 2023-11-21 | 60 | 0 |
| K230459 | C.C. Life 21 | 21 Equipment S.R.L. | 2023-10-19 | 240 | 0 |
| K232172 | BTL-785BNF Handpiece | BTL Industries, Inc. | 2023-09-18 | 59 | 0 |
| K220198 | Medi Lift PLUS | Ya-Man, Ltd. | 2023-06-28 | 520 | 0 |
| K230506 | PureLift Pro Edition | Xtreem Pulse | 2023-06-21 | 117 | 0 |
| K213078 | Myolift QT | Johari Digital Healthcare Limited | 2023-04-27 | 581 | 0 |
| K221443 | PureLift Pro Plus | Xtreem Pulse, LLC | 2022-10-21 | 156 | 0 |
| K214100 | Luminice | Premier North America, Inc. | 2022-02-24 | 57 | 0 |
| K211055 | Microcurrent device (Model: HBR2-1) | Shenzhen DJ Medical Equipment Co., Ltd. | 2021-11-05 | 210 | 0 |
| K212238 | TheraFace Microcurrent | Theragun, Inc. | 2021-09-29 | 72 | 0 |
| K212342 | ZIIP+ Device | Ziip, Inc. | 2021-09-23 | 57 | 0 |
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ | Avazzia, Inc. | 2021-04-27 | 645 | 0 |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | Carol Cole Company Dba Nuface | 2021-02-24 | 230 | 0 |
| K201680 | NuFACE Mini Plus | Carole Cole Company | 2021-02-19 | 242 | 0 |
| K201782 | NuFace Trinity Plus Device | Carol Cole Company Dba Nuface | 2021-01-22 | 206 | 0 |
| K192077 | Tua Face Fitness / Tua Trend Face | Vupiesse S.R.L | 2020-09-30 | 425 | 0 |
| K200803 | BEAR and BEAR mini | Foreo, Inc. | 2020-07-31 | 126 | 0 |
| K191672 | NuFACE Mini Device | Carol Cole Company Dba Nuface | 2019-10-15 | 113 | 0 |
| K190269 | PureLift | Xtreem Pulse, LLC | 2019-08-28 | 201 | 0 |
| K183189 | Ultra OTC Facial Toning System | Micro Current Technology, Inc. | 2019-04-17 | 149 | 0 |
| K182424 | NuFACE FIX Skin Toning Device | Carol Cole Company Dba Nuface | 2018-12-18 | 103 | 0 |
| K181008 | NuFACE Trinity | Carol Cole Company Dba Nuface | 2018-10-11 | 177 | 0 |
| K181062 | Ultra Facial Toning System | Micro Current Technology, Inc. | 2018-07-18 | 86 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda