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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K241530

Stellar Imaging System · Guangdong Optomedic Technologies, Inc. · decided 2024-08-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Stellar Camera HeadSC10EGuangdong Optomedic Technologies, Inc.GCJ06973031299429
Stellar 3D Camera HeadSC10DGuangdong Optomedic Technologies, Inc.GCJ06973031299405
Stellar 3D Fluorescence Camera HeadSC20DGuangdong Optomedic Technologies, Inc.GCJ06973031299399
Stellar Image Processing UnitSI10EGuangdong Optomedic Technologies, Inc.GCJ06973031299436
Stellar Exoscope31103FAGuangdong Optomedic Technologies, Inc.GCJ06973031299382
Stellar Fluorescence Camera Head SC20EGuangdong Optomedic Technologies, Inc.GCJ06973031299412
3D Laparoscope21033SAGuangdong Optomedic Technologies, Inc.GCJ06973031299344
Stellar Light SourceSL20Guangdong Optomedic Technologies, Inc.GCJ06973031299504
3D Laparoscope21033SCGuangdong Optomedic Technologies, Inc.GCJ06973031299337
Stellar Light Source SL10Guangdong Optomedic Technologies, Inc.GCJ06973031299375