Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OLI — Predicate Candidate Screening
33 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
297 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY- | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-05-04 | 62 | 0 |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-04-15 | 89 | 0 |
| K243854 | Contour Light (CL-100) | Contour Research, LLC | 2026-02-13 | 424 | 0 |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 2025-12-15 | 123 | 0 |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | 2025-12-01 | 90 | 0 |
| K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | 2025-01-10 | 30 | 0 |
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023-11-21 | 61 | 0 |
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | 2023-07-21 | 60 | 0 |
| K220519 | Erchonia Zerona Z-Bed | Erchonia Corporation | 2022-03-24 | 29 | 0 |
| K213534 | PHantom Trilogy | Resurgeonz, LLC | 2022-03-11 | 126 | 0 |
| K202955 | Contour Light CL-100 | Contour Research, LLC | 2021-05-19 | 231 | 0 |
| K202361 | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | 2020-12-18 | 121 | 0 |
| K192275 | invisa-RED ELITE | IR Technology, LLC | 2020-08-19 | 363 | 0 |
| K192544 | Erchonia Emerald | Erchonia Corporation | 2020-01-13 | 119 | 0 |
| K180338 | Cellulize | Ward Photonics, LLC | 2018-09-21 | 226 | 0 |
| K172111 | Vevazz LED | Vevazz, LLC | 2017-11-22 | 132 | 0 |
| K170709 | CURVE Laser System | Yolo Medical, Inc. | 2017-06-06 | 90 | 0 |
| K162578 | Zerona Z6 OTC | Erchonia Corporation | 2016-12-16 | 92 | 0 |
| K160880 | Photonica Professional | Ward Photonics, LLC | 2016-09-23 | 177 | 0 |
| K150446 | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | 2015-05-21 | 90 | 0 |
| K143741 | Lipofina Laser System | Yolo Medical, Inc. | 2015-04-24 | 114 | 0 |
| K143007 | Erchonia Zerona Z6 OTC | Erchonia Corporation | 2015-01-15 | 87 | 0 |
| K142042 | ERCHONIA SHL | Erchonia Corporation | 2014-10-21 | 85 | 0 |
| K134040 | BTL-9000; BTL-9000 RADIOFREQUENCY MODULE | Btl Industries, Ltd. | 2014-09-10 | 253 | 0 |
| K133718 | ZERONA | Erchonia Corporation | 2014-05-12 | 159 | 0 |
| K130341 | STRAWBERRY, STRAWBERRY & CREAM | Laser Lipo Limited | 2013-09-06 | 207 | 0 |
| K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER | Erchonia Medical, Inc. | 2013-05-17 | 44 | 0 |
| K123237 | ZERONA 2.0 LASER | Erchonia Corporation | 2013-01-25 | 101 | 0 |
| K121695 | ERCHONIA ZERONA | Erchonia Corporation | 2012-08-23 | 77 | 0 |
| K121690 | ETCHONIA ZERONA ARMS | Erchonia Corporation | 2012-08-23 | 77 | 0 |
| K120257 | MLS, ZERONA-AD | Erchonia Medical, Inc. | 2012-05-14 | 108 | 0 |
| K111501 | I-LIPO SYSTEM | Chromogenex Technologies Limited | 2012-03-23 | 297 | 0 |
| DEN090008 | ERCHONIA ML SCANNER (MLS) | Erchonia Medical | 2010-08-24 | 596 | 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