Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

116 daysmedian FDA review time
289 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2024-12-26900
K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2024-02-281630
K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2022-09-23570
K183122810nm Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2019-08-252890
K163655SparklingShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2017-03-17840
K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd2016-09-091160

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