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510(k) K200516

OCT-Camera ID 21101A3 by Optomedical Technologies GmbH — Product Code OBO

K200516 is an FDA 510(k) premarket notification submitted by Optomedical Technologies GmbH for the device "OCT-Camera ID 21101A3". The FDA issued a decision of Substantially Equivalent on September 2, 2020. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Optomedical Technologies GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2020
Date Received
March 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tomography, Optical Coherence
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Optomedical Technologies GmbH

  • K142953 — OCT-Camera (March 4, 2015)

Other clearances for product code OBO

  • K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (May 7, 2026)
  • K252633 — UNITY DX (UDX) (December 23, 2025)
  • K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
  • K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
  • K240924 — Anterion (December 13, 2024)
  • K241163 — SPECTRALIS with Flex Module (October 11, 2024)
  • K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
  • K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
  • K233933 — CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
  • K233602 — P200TE (A10700) (May 9, 2024)

FDA data resources