Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HQF — Predicate Candidate Screening
180 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
267 days90th percentile
180clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | 2026-04-07 | 202 | 0 |
| K251507 | INTEGRE LIO | Quantel Medical | 2026-02-06 | 266 | 0 |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025-10-29 | 141 | 0 |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | 2025-06-18 | 264 | 0 |
| K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | 2025-04-03 | 394 | 1 |
| K242397 | LYNX Photocoagulator | Norlase Aps | 2024-10-25 | 73 | 0 |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024-09-06 | 269 | 0 |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | 2024-01-25 | 167 | 0 |
| K230722 | Eagle device | Belkin Vision, Ltd. | 2023-12-08 | 267 | 0 |
| K232051 | VISULAS green | Carl Zeiss Meditec | 2023-10-24 | 106 | 0 |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023-09-22 | 225 | 0 |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 | Meridian AG | 2023-09-12 | 155 | 0 |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and | Iridex Corporation | 2023-02-23 | 27 | 0 |
| K220974 | R:GEN | Lutronic Vision, Inc. | 2022-12-27 | 267 | 0 |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532n | Iridex Corporation | 2022-11-09 | 37 | 0 |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | 2022-11-02 | 86 | 0 |
| K222157 | ECHO Photocoagulator | Norlase | 2022-10-11 | 83 | 0 |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Tr | Lumenis Be, Inc. | 2022-07-15 | 112 | 0 |
| K220430 | Capsulo | Quantel Medical | 2022-05-12 | 86 | 0 |
| K213592 | Iridex 810 Laser | Iridex Corporation | 2022-03-23 | 131 | 0 |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | 2021-12-16 | 119 | 0 |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2020-12-07 | 49 | 0 |
| K202760 | Iridex 810 Laser | Iridex Corporation | 2020-10-21 | 30 | 0 |
| K201623 | LION Photocoagulator | Norlase Aps | 2020-08-11 | 57 | 0 |
| K201502 | Vitra 810 | Quantel Medical | 2020-08-06 | 62 | 0 |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019-11-15 | 107 | 0 |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med(Usa), Inc. | 2019-05-24 | 88 | 0 |
| K190083 | Leaf Photocoagulator | Norlase Aps | 2019-05-03 | 106 | 0 |
| K181682 | VISULAS green | Carl Zeiss Meditec, AG | 2019-03-06 | 253 | 0 |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinS | Topcon Medical Laser Systems, Inc. | 2018-05-25 | 100 | 0 |
| K171488 | PSLT for PASCAL Streamline | Topcon Medical Laser Systems, Inc. | 2017-11-27 | 189 | 0 |
| K170067 | Easyret | Quantel Medical | 2017-07-25 | 197 | 0 |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Nidek Co., Ltd. | 2017-06-23 | 143 | 0 |
| K153769 | R:GEN Laser System | Lutronic Corporation | 2016-10-05 | 280 | 0 |
| K152688 | LightLas Multi-Wavelength Medical Laser System | Lightmed Corporation | 2016-06-15 | 271 | 0 |
| K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016-05-02 | 234 | 0 |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro | Ellex Medical Pty, Ltd. | 2015-07-14 | 321 | 1 |
| K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015-06-25 | 268 | 0 |
| K142172 | LIGHTMED TRUSCAN 577 | Lightmed Corp. | 2015-02-27 | 204 | 0 |
| K133019 | FIBERION OPHTHALMIC ENDOLASER PROBE | Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim | 2015-02-20 | 512 | 0 |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATE | Katalyst Surgical, LLC | 2014-09-15 | 215 | 0 |
| K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECT | Nidek Co., Ltd. | 2014-08-12 | 285 | 2 |
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | Quantel Medical | 2014-06-25 | 135 | 0 |
| K130195 | SCANNING LASERLINK | Lumenis, Inc. | 2013-11-01 | 277 | 1 |
| K131207 | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER | Surgical Instrument Engineering AG | 2013-10-09 | 163 | 1 |
| K124043 | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Lightmed Corp. | 2013-09-26 | 272 | 0 |
| K130933 | SOLUTIS | Quantel Medical | 2013-08-02 | 120 | 0 |
| K122202 | ELLEX 2RT | Ellex Medical Pty, Ltd. | 2013-07-01 | 341 | 0 |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | Topcon Medical Laser Systems, Inc. | 2013-05-15 | 177 | 0 |
| K123056 | PASCAL LASER INDIRECT OPHTHALMOSCOPE | Topcon Medical Laser Systems, Inc. (Tmls) | 2012-11-13 | 43 | 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