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Quantel Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251507INTEGRE LIOFebruary 6, 2026
K232302Pocket IIIApril 26, 2024
K220430CapsuloMay 12, 2022
K213254Axialis Ophthalmic Ultrasound SystemNovember 15, 2021
K201502Vitra 810August 6, 2020
K191962Vitra 2December 5, 2019
K183414ABSOLUMarch 20, 2019
K180265COMPACT TOUCH Ophthalmic Ultrasound SystemMarch 2, 2018
K170067EasyretJuly 25, 2017
K140336OPTIMUS FUSION: SLT, YAG AND YAG/SLTJune 25, 2014
K130933SOLUTISAugust 2, 2013
K122251VITRA MULTISPOTJanuary 24, 2013
K120825SUPRA SCAN DELIVERY SYSTEMSeptember 14, 2012
K102027AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEMDecember 22, 2010
K102198COMPACT TOUCH STSNovember 5, 2010
K100678SUPRA SCAN DELIVERY SYSTEMJuly 21, 2010
K091581SUPRA 577.Y LASERJune 16, 2009
K081946SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATORMarch 25, 2009
K073066308 DERMATOLOGICAL EXCIMER SYSTEMDecember 26, 2007
K070776SUPRA OPHTHALMIC LASER PHOTOCOAGULATORApril 24, 2007