Last synced on 25 January 2026 at 3:41 am

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221781
510(k) Type
Traditional
Applicant
Guangdong Optomedic Technologies, Inc.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/2/2023
Days to Decision
226 days
Submission Type
Summary

Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221781
510(k) Type
Traditional
Applicant
Guangdong Optomedic Technologies, Inc.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/2/2023
Days to Decision
226 days
Submission Type
Summary