Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NVK · Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
219 daysmedian FDA review time
438 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Auror | Shenzhen Soga Technology Co., Ltd. | 2026-05-19 | 232 | 0 |
| K260765 | Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC | 2026-03-10 | 1 | 0 |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) | Matelaser, Inc. | 2025-10-16 | 219 | 0 |
| K243764 | Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU | Wuhan Pioon Technology Co., Ltd. | 2025-05-08 | 153 | 0 |
| K230047 | Medical Diode Laser Systems | Gigaalaser Company , Ltd. | 2024-03-04 | 423 | 0 |
| K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-02-28 | 163 | 0 |
| K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo | Medency S.R.L. | 2023-11-27 | 124 | 0 |
| K221761 | Solea | Convergent Dental, Inc. | 2022-09-14 | 89 | 1 |
| K211150 | Dental diode laser, SOGA Laser, ILaser II | Shenzhen Soga Technology Co., Ltd. | 2022-07-01 | 438 | 0 |
| K214008 | Dental diode laser | Shenzhen Soga Technology Co., Ltd. | 2022-05-10 | 139 | 0 |
| K213658 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | 2022-03-11 | 112 | 0 |
| K210367 | D-Laser Blue, D-Laser 16 | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-03-10 | 395 | 0 |
| K213428 | EdgePro | Biolase, Inc. | 2021-12-22 | 62 | 0 |
| K210350 | Gemini 2 810+980 Soft Tissue Laser | Azena Medical, LLC | 2021-11-18 | 283 | 0 |
| K203396 | DEKA SMARTPERIO | El.En Electronic Engineering Spa | 2021-08-23 | 278 | 0 |
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | 2021-02-26 | 275 | 0 |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | Kavo America | 2005-08-03 | 931 | 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