Chrysalis Intelligence · Product Codes · OWN

OWN · Confocal Optical Imaging

Gastroenterology, Urology · 32 clearances · 20 unique sponsors

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Device class
Class II
Regulation 876.1500
Total clearances
32
2020-01-24 → 2026-09-21
Last 12 months
8
Unique sponsors
20
Definition

What is Confocal Optical Imaging

Collection of light signals for visualization of cellular microstructures.
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
SU
Regulation number
876.1500
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
Karl Storz SE & CO. KG 4 2 2026-02-26
Mauna Kea Technologies 4 0 2022-04-11
Stryker 3 0 2023-09-20
Olympus Medical Systems Corp. 2 1 2025-11-12
Activ Surgical, Inc. 2 0 2023-08-02
Visionsense, Ltd. 2 0 2022-10-28
Novadaq Technologies Ulc. (Now A Part of Stryker) 2 0 2020-11-05
Karl Storz Endoscopy America 1 0 2021-11-15
Smartsurgn Incorporated 1 0 2022-11-29
Karl Storz Endoscopy_America, Inc. 1 0 2020-12-17
KALR STORZ SE & Co. KG 1 1 2026-09-21
VPIX Medical, Inc. 1 1 2026-02-13
Stryker Endoscopy 1 1 2026-02-12
Samantree Medical SA 1 0 2024-08-19
SmartsurgN, Inc. 1 1 2026-04-20
Optosurgical, LLC 1 0 2025-02-19
Wuxi Hisky Medical Technologies Co., Ltd. 1 0 2025-07-24
LIMIS Development B.V. 1 1 2026-07-24
Karl Storz-Endoscopy-America, Inc. 1 0 2020-08-17
Guangdong Optomedic Technologies, Inc. 1 0 2023-07-17
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
43198 CPT — Medium Esophageal ultrasound (EUS) including collection of specimen(s) by brushing or biopsy
52007 CPT — Medium Cystourethroscopy, with collection of specimens by brushing of urothelial and bladder wall
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-21 K262547 KALR STORZ SE & Co. KG KARL STORZ TIPCAM1 Rubina
2026-07-24 K254180 LIMIS Development B.V. PerfusiX-Imaging
2026-04-20 K242163 SmartsurgN, Inc. SmartSurgN Visualization System
2026-02-26 K254242 Karl Storz SE & CO. KG KARL STORZ ICG Imaging System with RUBINA® Lens
2026-02-13 K251852 VPIX Medical, Inc. cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
2026-02-12 K260108 Stryker Endoscopy L12 LED Light Source with AIM
2026-02-12 K253972 Karl Storz SE & CO. KG IMAGE1 (TC400US); X-to-4U Adapter (TC040)
2025-11-12 K251336 Olympus Medical Systems Corp. VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
2025-07-24 K243711 Wuxi Hisky Medical Technologies Co., Ltd. Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
2025-02-19 K243591 Optosurgical, LLC OPTOVISION Endoscopic Light Source Unit
2024-08-19 K241275 Samantree Medical SA Histolog® Scanner (Hardware 2.4, Software 3.3)
2023-11-21 K233333 Karl Storz SE & CO. KG KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
2023-11-06 K232857 Karl Storz SE & CO. KG KARL STORZ ICG Imaging System
2023-09-20 K231854 Stryker 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
2023-08-02 K231344 Activ Surgical, Inc. ActivSight Intraoperative Imaging System
2023-07-17 K230407 Guangdong Optomedic Technologies, Inc. FloNavi Open Field Fluorescence Imaging System
2023-04-11 K230754 Stryker L12 LED Light Source with AIM
2022-11-29 K213943 Smartsurgn Incorporated SmartSurgN Visualization System
2022-10-28 K223020 Visionsense, Ltd. VS3-Iridium System (VS3-IR)
2022-06-29 K221611 Stryker 780 nm L11 LED Light Source with AIM
2022-04-11 K220477 Mauna Kea Technologies Cellvizio 100 series system with confocal Miniprobes
2021-11-22 K210265 Visionsense, Ltd. VS3 Iridium Sytem
2021-11-15 K212695 Karl Storz Endoscopy America KARL STORZ ICG Imaging System
2021-08-18 K212322 Mauna Kea Technologies Cellvizio I.V.E. system with Confocal Miniprobes
2021-04-08 K203550 Activ Surgical, Inc. ActivSight Intraoperative Imaging System
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence