Chrysalis Intelligence · Product Codes · OBO

OBO · Tomography, Optical Coherence

Ophthalmic · 24 clearances · 10 unique sponsors

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Device class
Class II
Regulation 886.1570
Total clearances
24
2020-09-02 → 2026-05-07
Last 12 months
2
Unique sponsors
10
Definition

What is Tomography, Optical Coherence

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Classification details
Medical specialty
Ophthalmic
Review panel
OP
Regulation number
886.1570
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Heidelberg Engineering GmbH 9 1 2026-05-07
Topcon Corporation 3 0 2024-07-17
Carl Zeiss Meditec, AG 3 0 2024-05-17
Optos Plc. 2 0 2024-05-09
Tomey Corporation 2 0 2025-07-18
Optovue, Inc. 1 0 2022-11-09
Optomedical Technologies GmbH 1 0 2020-09-02
Cylite Pty. , Ltd. 1 1 2025-12-23
Nidek Co., Ltd. 1 0 2023-03-30
C.S.O. S.R.L. 1 0 2023-09-01
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92133 CPT — High Scanning computerized ophthalmic diagnostic imaging; OCT is standard diagnostic imaging for eye
92134 CPT — Medium Scanning laser ophthalmoscopy or OCT with interpretation and report
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-07 K253837 Heidelberg Engineering GmbH SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module
2025-12-23 K252633 Cylite Pty. , Ltd. UNITY DX (UDX)
2025-07-18 K250553 Tomey Corporation Tomey Cornea/Anterior Segment OCT (CASIA2)
2025-05-12 K250868 Heidelberg Engineering GmbH SPECTRALIS HRA+OCT and variants
2024-12-13 K240924 Heidelberg Engineering GmbH Anterion
2024-10-11 K241163 Heidelberg Engineering GmbH SPECTRALIS with Flex Module
2024-07-17 K241081 Topcon Corporation 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
2024-07-01 K240221 Heidelberg Engineering GmbH SPECTRALIS HRA+OCT and variants
2024-05-17 K233933 Carl Zeiss Meditec, Inc. CIRRUS™ HD-OCT Model 6000
2024-05-09 K233602 Optos Plc. P200TE (A10700)
2024-04-10 K233561 Topcon Corporation 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
2024-03-08 K233421 Carl Zeiss Meditec, AG RESCAN 700
2023-10-30 K231222 Topcon Corporation 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
2023-10-20 K223557 Heidelberg Engineering GmbH SPECTRALIS HRA+OCT and variants
2023-10-11 K230897 Heidelberg Engineering GmbH Anterion
2023-09-01 K221601 C.S.O. S.R.L. MS-39
2023-08-18 K231673 Optos Plc. P200TE (A10700)
2023-04-13 K222200 Carl Zeiss Meditec, Inc. CIRRUS HD-OCT
2023-03-30 K221320 Nidek Co., Ltd. Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
2022-11-09 K222166 Optovue, Inc. SOLIX
2022-04-27 K213265 Tomey Corporation Tomey Cornea/Anterior Segment OCT CASIA2
2021-11-05 K211817 Heidelberg Engineering GmbH Anterion
2020-09-09 K201252 Heidelberg Engineering GmbH Spectralis HRA+OCT and variants
2020-09-02 K200516 Optomedical Technologies GmbH OCT-Camera ID 21101A3
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence