Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantel Medical — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
260 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251507 | INTEGRE LIO | Quantel Medical | 2026-02-06 | 266 | 0 |
| K232302 | Pocket III | Quantel Medical | 2024-04-26 | 269 | 0 |
| K220430 | Capsulo | Quantel Medical | 2022-05-12 | 86 | 0 |
| K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | 2021-11-15 | 46 | 0 |
| K201502 | Vitra 810 | Quantel Medical | 2020-08-06 | 62 | 0 |
| K191962 | Vitra 2 | Quantel Medical | 2019-12-05 | 135 | 0 |
| K183414 | ABSOLU | Quantel Medical | 2019-03-20 | 100 | 0 |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Quantel Medical | 2018-03-02 | 30 | 0 |
| K170067 | Easyret | Quantel Medical | 2017-07-25 | 197 | 0 |
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | Quantel Medical | 2014-06-25 | 135 | 0 |
| K130933 | SOLUTIS | Quantel Medical | 2013-08-02 | 120 | 0 |
| K122251 | VITRA MULTISPOT | Quantel Medical | 2013-01-24 | 181 | 0 |
| K120825 | SUPRA SCAN DELIVERY SYSTEM | Quantel Medical | 2012-09-14 | 179 | 0 |
| K100678 | SUPRA SCAN DELIVERY SYSTEM | Quantel Medical | 2010-07-21 | 133 | 0 |
| K091581 | SUPRA 577.Y LASER | Quantel Medical | 2009-06-16 | 14 | 0 |
| K081946 | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | Quantel Medical | 2009-03-25 | 260 | 0 |
| K070776 | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | Quantel Medical | 2007-04-24 | 34 | 0 |
| K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM | Quantel Medical | 2005-08-03 | 26 | 0 |
| K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OP | Quantel Medical | 2005-03-24 | 84 | 0 |
| K043236 | FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA | Quantel Medical | 2005-02-07 | 77 | 0 |
| K032260 | ARAMIS II DERMATOLOGICAL LASER | Quantel Medical | 2003-11-20 | 121 | 0 |
| K023734 | ARAMIS II DERMATOLOGICAL LASER | Quantel Medical | 2003-05-06 | 180 | 0 |
| K023464 | VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR | Quantel Medical | 2003-01-13 | 90 | 0 |
| K023094 | IRIDIS OPHTHALMIC PHOTOCOAGULATOR | Quantel Medical | 2002-12-17 | 90 | 0 |
| K021650 | ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR | Quantel Medical | 2002-08-16 | 88 | 0 |
| K021683 | CINESCAN S | Quantel Medical | 2002-06-21 | 30 | 0 |
| K020072 | ATHOS LASER | Quantel Medical | 2002-04-09 | 90 | 0 |
| K020071 | VIRIDIS DERMA LASER | Quantel Medical | 2002-04-05 | 86 | 0 |
| K993674 | POCKET ULTRASONIC PACHYMETER | Quantel Medical | 2000-07-13 | 255 | 0 |
| K000554 | POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER | Quantel Medical | 2000-03-14 | 25 | 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