HKI · Camera, Ophthalmic, Ac-Powered · Chrysalis Intelligence

Device class

Class II

Regulation 886.1120

Total clearances

2020-01-22 → 2026-06-22

Last 12 months

Unique sponsors

Classification details

Medical specialty

Ophthalmic

Review panel

Regulation number

886.1120

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Optina Diagnostics, Inc.	3	1	2025-09-04
Phelcom Technologies	2	1	2026-01-16
Canon, Inc.	2	0	2024-05-15
Beyond 700 Pty, Ltd.	1	1	2026-06-22
Luneau Technology Operations	1	0	2021-01-29
Zilia, Inc.	1	0	2023-11-20
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)	1	0	2021-04-13
Forus Health Pvt.Ltd	1	0	2025-08-14
Neolight, LLC	1	0	2023-09-06
Ai Optics	1	0	2024-12-17
Crystalvue Medical Corporation	1	0	2021-04-13
Welch Allyn, Inc.	1	0	2023-03-15
Vasoptic Medical, Inc.	1	0	2020-06-01
Remidio Innovative Solutions Private Limited	1	1	2025-12-12
Topcon Corporation	1	0	2022-08-29
Optain Health, Inc.	1	0	2025-04-30
Optomed Oyj	1	0	2020-11-20
Huvitz Co., Ltd.	1	0	2021-02-02
Chongqing Bio Newvision Medical Equipment , Ltd.	1	0	2020-01-22
Verily Life Sciences, LLC	1	0	2024-12-09

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.

Code	Type	Description	Confidence	Rationale
92004	CPT	—	Medium	Comprehensive eye exam; ophthalmic camera is diagnostic imaging component
92012	CPT	—	Medium	Ophthalmology visit for established patient; camera aids examination

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-22	K253176	Beyond 700 Pty, Ltd.	TearView
2026-01-16	K251353	Phelcom Technologies	Eyer 2
2025-12-12	K252120	Remidio Innovative Solutions Private Limited	Fundus On Phone Non Mydriatic (FOP NM-10)
2025-09-04	K250770	Optina Diagnostics, Inc.	Optina-4C (MHRC-C1N)
2025-08-14	K243600	Forus Health Pvt.Ltd	3nethra neo HD FA; 3nethra neo HD
2025-04-30	K250683	Optain Health, Inc.	Resolve Fundus Camera
2024-12-17	K243664	Ai Optics	Sentinel Camera
2024-12-09	K242508	Verily Life Sciences, LLC	Verily Numetric Retinal Camera
2024-05-15	K241049	Canon, Inc.	CANON Fundus Camera CR-10 (CR-10)
2023-12-05	K231230	Optina Diagnostics, Inc.	Optina-4C (MHRC-C1N)
2023-11-20	K230627	Zilia, Inc.	Zilia Ocular FC (ZIL-10002)
2023-09-06	K223575	Neolight, LLC	Phoenix ICON, Phoenix ICON GO
2023-03-15	K223381	Welch Allyn, Inc.	iExaminer System with Panoptic Plus
2023-02-22	K221329	Phelcom Technologies	Eyer Retinal Camera NM-STD
2022-08-29	K221111	Topcon Corporation	Non-Mydriatic Retinal Camera NW500
2021-04-13	K210197	Crystalvue Medical Corporation	NFC-600 Automated Portable Retinal Camera
2021-04-13	K203500	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)	RetCam Envision
2021-02-02	K202097	Huvitz Co., Ltd.	Fundus Camera
2021-01-29	K202221	Luneau Technology Operations	VX650
2020-11-20	K201325	Optomed Oyj	Optomed Smartscope M5 with Optomed Smartscope FA
2020-07-23	K201122	Canon, Inc.	Canon non-mydriatic retinal camera CR series
2020-06-01	K193319	Vasoptic Medical, Inc.	XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
2020-04-27	K200254	Optina Diagnostics	Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
2020-01-22	K190954	Chongqing Bio Newvision Medical Equipment , Ltd.	Fundus Camera