Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ONF — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
113 daysmedian FDA review time
276 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261204 | Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 | 60 | 0 |
| K251545 | Intense Pulsed Light Therapy Device (MMABM-1) | Micowey Medical Equipment (Guangxi) Co., Ltd. | 2025-09-04 | 107 | 0 |
| K231952 | MEDILIGHT | Medicreations, LLC | 2025-09-03 | 796 | 0 |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | 2025-07-03 | 276 | 0 |
| K250281 | DEKA LOTUS | El.En S.P.A. | 2025-02-26 | 26 | 0 |
| K242440 | Intense Pulsed Light Treatment System (LK-PT) | Nanjing Bestview Laser S&T Co., Ltd. | 2024-11-14 | 90 | 0 |
| K240314 | MULA (K2-A1) | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | 2024-08-21 | 201 | 0 |
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 | 87 | 0 |
| K233473 | DEKA LOTUS | El.En S.P.A. | 2024-05-16 | 204 | 0 |
| K233307 | Intensity Pulsed Light Therapy System | Beijing Adss Development Co., Ltd. | 2024-03-15 | 168 | 0 |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co., Ltd. | 2023-12-01 | 87 | 0 |
| K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023-09-11 | 49 | 0 |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 | 86 | 0 |
| K230816 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2023-04-21 | 28 | 0 |
| K220214 | Painless IPL System - KDT750 | Shanghai Omni Laser Skinology Co., Ltd. | 2023-02-18 | 388 | 0 |
| K220794 | 10PL | Tentech Co. , Ltd. | 2022-11-10 | 237 | 0 |
| K221214 | Hand-held IPL device (IPL Home Use Hair Removal Device) Mode | Shenzhen Ionka Medical Technology Co., Ltd. | 2022-09-21 | 147 | 0 |
| K220385 | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | 2022-08-12 | 183 | 0 |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd. | 2022-03-08 | 120 | 0 |
| K212907 | Aimanfun Lumea Comfort, A-2789/A-3588 | Kam Yuen Plastic Products , Ltd. | 2021-12-02 | 80 | 0 |
| K211368 | IPL Hair Remover, Model: G993, G996, G998 and G885 | Shenzhen Mywin Technology Co., Ltd. | 2021-10-04 | 153 | 0 |
| K212099 | Red Wave Hair Removal | Shenzhen Accompany Technology Co., Ltd. | 2021-09-24 | 80 | 0 |
| K210119 | IPL Hair Removal Device (Model: KCA423) | Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. | 2021-05-21 | 122 | 0 |
| K200616 | E>EyeC | E-Swin | 2020-06-11 | 94 | 0 |
| K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020-05-15 | 53 | 0 |
| K193328 | IPL + Diode Laser Machine | Beijing Globalipl Development Co., Ltd. | 2020-03-25 | 114 | 0 |
| K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | 2020-03-05 | 122 | 0 |
| K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019-12-06 | 84 | 0 |
| K192519 | Multi-modality workstation | Beijing Superlaser Technology Co., Ltd. | 2019-11-27 | 75 | 0 |
| K181868 | SHINY RPL System | Ids, Ltd. | 2018-10-05 | 85 | 0 |
| K181298 | Harmony XL Multi-Application Platform | Alma Lasers, Inc. | 2018-06-13 | 28 | 0 |
| K161565 | DUO | Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd | 2016-09-01 | 87 | 0 |
| K161286 | IPL Therapy Machine | Beijing Adss Development Co., Ltd. | 2016-08-04 | 87 | 0 |
| K160195 | Forma System, Forma Light System | Formatk Systems , Ltd. | 2016-04-15 | 79 | 0 |
| K153717 | Venus Versa System | Venus Concept , Ltd. | 2016-03-21 | 88 | 0 |
| K152790 | Venus Versa System | Venus Concept , Ltd. | 2016-01-20 | 117 | 0 |
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Ac | Shaser, Inc. | 2015-05-27 | 111 | 0 |
| K150051 | Exilite | BTL Industries, Inc. | 2015-04-08 | 86 | 0 |
| K141237 | HARMONY LITE | Alma, Inc. | 2015-03-13 | 304 | 0 |
| K140668 | PLATINUMGMT IPL SYSTEM CLOUD | Global Medical Technology S.L. | 2014-12-19 | 276 | 0 |
| K143339 | Mini me | Iluminage Ltd.(Formerly Syneron Beauty Ltd.) | 2014-12-19 | 29 | 0 |
| K140670 | ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ | Ellipse A/S | 2014-09-25 | 191 | 0 |
| K141583 | SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY | Shaser, Inc. | 2014-07-22 | 39 | 0 |
| K131712 | A-TONE IPL SYSTEM | Ybk Investment, Inc. | 2014-05-30 | 353 | 0 |
| K140631 | LUMENA FH HAIR REMOVAL SYSTEM | Shaser, Inc. | 2014-05-16 | 65 | 0 |
| K133201 | SHASER V-MINI 2 HAIR REMOVAL SYSTEM | Shaser, Inc. | 2014-02-12 | 118 | 0 |
| K131649 | ME | Syneron Beauty , Ltd. | 2013-12-11 | 189 | 0 |
| K132170 | SHASER V-MINI RX | Shaser, Inc. | 2013-11-26 | 134 | 0 |
| K131859 | MULTIFUNCTIONAL SERIES | Beijing Honkon Technologies Co., Ltd. | 2013-10-18 | 116 | 0 |
| K132266 | SHASER HRS2 RX HAIR REMOVAL SYSTEM | Shaser, Inc. | 2013-09-30 | 70 | 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