ABSOLU

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K183414Ref ABSOLU

by Quantel Medical

Identity

Trade Name: ABSOLU EUDAMEDFDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Device Name: ABSOLU EUDAMED
The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit. FDA UDI
Model / Reference: ABSOLU EUDAMEDFDA UDI
Description: The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit. FDA UDI

Identifiers

Primary DI / UDI-DI: 03700542625521 EUDAMEDFDA UDI
Basic UDI-DI: 37005426ABSOLUAP EUDAMED
510(k) Number: K183414 FDA 510(k)FDA UDI
FDA Product Code: IYO FDA 510(k)FDA UDI
EMDN Code: Z11040107 ECHOPHTHALMOGRAPHS EUDAMED
GMDN Term: Ophthalmic ultrasound imaging system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 892.1560 FDA 510(k)
Regulation Number: 892.1560 FDA 510(k)FDA UDI
Market of Registration: Italy EUDAMED
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

The ABSOLU is a high-frequency ultrasound imaging system designed for anterior segment and ultrasound biomicroscopy (UBM) applications. It employs 5-ring annular technology at 20 MHz to generate detailed cross-sectional images of the eye, enabling comprehensive visualization of ocular structures with enhanced resolution and depth of field.

This device is intended for use in ophthalmic settings, providing real-time imaging for diagnostic and surgical planning. Supplied as a reusable medical device, it requires appropriate sterilization and maintenance protocols. The ABSOLU holds FDA 510(k) clearance under the Traditional pathway and is compliant with MDR regulations. Authorized for clinical use in the United States and European Union, it is classified under product code IYO.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ABSolu, the ultimate A/B/S/UBM ultrasound platform - Lumibird Medical, Lumibird Quantel Medical ABSolu® A/B/S/UBM Ultrasound Platform, Quantel Medical - Lumibird Medical, Absolu - Top Ophthalmic Products & Services Corp.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K183414	Class II	Active

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Manufacturer

Manufacturer: Quantel Medical

Sources (3)

FDA 510(k) K183414 24 fields · synced Sep 18, 2026
FDA UDI 2b4fefce-afdb-47cb-afe7-0edb42523ec0 35 fields · synced May 30, 2026
EUDAMED 85dd8e4e-e4a4-4684-a87a-9af3f3333568 61 fields · synced Jul 21, 2026