LIGHTSonic B UBM

FDA UDI

Class II (US FDA UDI)

by Light-Med(Usa), Inc.

Identity

Trade Name: LIGHTSonic B UBM FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Model / Reference: US0000 FDA UDI

Identifiers

Primary DI / UDI-DI: 00853386006285 FDA UDI
510(k) Number: K170761 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic ultrasound imaging system

LIGHTSonic B UBM by Light-Med(Usa), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic ultrasound imaging system.

A-scan probe — Nidek, Inc. · Class II
ArcScan Insight 100 — Arcscan, Inc. · Class II
Ultrasonic A/B Scanner for Ophthalmology — Meda , Ltd. · Class II
Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
Ellex — ELLEX MEDICAL PTY LTD · Class II
Ophthalmic Ultrasound Examination Instrument — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO., LTD · Class II
B-scan Plus- VET — ACCUTOME, INC. · Class II
A-scan probe — Nidek, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Light-Med(Usa), Inc.

Sources (1)

FDA UDI 43dc2d6e-da77-4960-9558-e6ac0db83163 33 fields · synced May 30, 2026