Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ILY — Predicate Candidate Screening
229 FDA 510(k) clearances under this product code; the 50 most recent screened below.
151 daysmedian FDA review time
286 days90th percentile
229clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; Cur | Wuhan PHOMED Technology Company , Ltd. | 2026-03-19 | 98 | 0 |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBO | Gigaalaser Company , Ltd. | 2025-05-19 | 249 | 0 |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | 2024-10-15 | 468 | 0 |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023-03-09 | 93 | 0 |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | 2022-08-29 | 126 | 0 |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | 2022-08-10 | 280 | 0 |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | 2020-12-16 | 147 | 0 |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017-07-07 | 86 | 0 |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (H | Healthlight, LLC | 2017-06-13 | 222 | 0 |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017-05-05 | 116 | 0 |
| K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017-02-14 | 151 | 0 |
| K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017-01-05 | 97 | 0 |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | 2016-12-15 | 262 | 0 |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | 2016-07-29 | 368 | 0 |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016-07-26 | 89 | 0 |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | 2016-07-08 | 315 | 0 |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX | Usa Laser Biotech, Inc. | 2016-07-05 | 91 | 0 |
| K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016-07-05 | 224 | 0 |
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysi | In Light Wellness Systems, Inc. | 2016-03-30 | 128 | 0 |
| K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016-03-02 | 203 | 0 |
| K150716 | Varaya Sport | Varaya Photoceuticals, LLC | 2015-12-08 | 264 | 0 |
| K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015-10-06 | 216 | 0 |
| K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015-09-04 | 91 | 0 |
| K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015-08-21 | 94 | 0 |
| K150466 | ZX2 Laser System | Lzr7, Inc. | 2015-06-08 | 105 | 0 |
| K150175 | HeatLux Pro I | Home Skinovations , Ltd. | 2015-03-31 | 64 | 0 |
| K141892 | QK-SYSTEMIC THERAPEUTIC APPARATUS | Harbin Quanke Medi-Technical Development Co., Ltd. | 2015-01-28 | 198 | 0 |
| K142025 | NEUROLUMEN PN-1000 | Neurolumen, LLC | 2015-01-21 | 180 | 0 |
| K142722 | 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 | Livetec GmbH | 2015-01-13 | 112 | 0 |
| K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Applied Biophotonics , Ltd. | 2015-01-07 | 146 | 0 |
| K141861 | HILTHERA 4.0 | Jeisys Medical, Inc. | 2015-01-07 | 181 | 0 |
| K142340 | Infrared Therapy System | Beijing Huatai Healthcare Technology Co., Ltd. | 2014-12-02 | 103 | 0 |
| K142215 | Power Twin21-50/Power Twin21-100 | Livetec GmbH | 2014-11-07 | 87 | 0 |
| K142078 | VELASII THERAPY LASER SYSTEM | Aspen Laser Systems, LLC | 2014-10-30 | 91 | 0 |
| K141564 | OPTON PRO | Zimmer Medizinsystems GmbH | 2014-10-24 | 134 | 0 |
| K140865 | INFRARED HEATING DEVICE | Pro Medical Supplies, Inc. | 2014-09-03 | 153 | 0 |
| K131080 | PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LI | Reimers and Janssen GmbH | 2014-06-13 | 445 | 0 |
| K132016 | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM | Texas Applied Biomedical Services, Inc. | 2014-06-02 | 336 | 0 |
| K132529 | GALLIEON-1 MEDICAL LASER | Future Device and Technology, Inc. | 2014-05-12 | 273 | 0 |
| K134017 | GIGALASER | Powermedic Aps | 2014-05-02 | 123 | 0 |
| K131113 | BIOPHOTAS CELLUMA | Biophotas, Inc. | 2014-01-15 | 268 | 0 |
| K130168 | CL10009 IR LASER | Curae'Lase, Inc. | 2014-01-10 | 351 | 0 |
| K131259 | LASER-STIM | Shenzhen Dongdixin Technology Co., Ltd. | 2013-12-27 | 239 | 0 |
| K123474 | AVANT LASER | Avant Wellness Systems, LLC | 2013-12-03 | 385 | 0 |
| K130866 | BIOLIGHT BIODYNAM | Biolight AB | 2013-10-25 | 211 | 0 |
| K131797 | 3B LASER NEEDLE | Livetec GmbH | 2013-10-10 | 114 | 0 |
| K123177 | STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM | Laserstim, Inc. | 2013-07-03 | 267 | 0 |
| K123971 | CYNOSURE 1064NM DIODE LASER | Cynosure, Inc. | 2013-05-02 | 127 | 0 |
| K121401 | TENDER TOUCH | Sometech Corporation | 2013-05-01 | 356 | 0 |
| K122125 | ASA LASER SH1 | El.En Electronic Engineering Spa | 2013-01-25 | 191 | 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