# FL800 Ult

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/fl800-ult-10449023>
- Manufacturer: [Leica Microsystems (Schweiz) AG](https://devicerts.com/manufacturers/fda-fei-3003974370) (Switzerland)
- Name in the registry: FL800 ULT
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: IZI
- EMDN: Z12011199 INSTRUMENTS FOR OPERATIVE MICROSCOPY – OTHER
- GMDN: Surgical microscope fluorescent angiography system (57883)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 76300035FL8007W · UDI-DI 07630003593587 · registered 2025-11-10 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07630003593587 · listed 2018-11-20 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K080612 · issued 2008-05-09 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: FL800 ULT [EUDAMED]; Leica FL800 ULT [FDA GUDID (AccessGUDID)]
- Generic name: Surgical microscope fluorescent angiography system [FDA GUDID (AccessGUDID)]
- Model / reference: FL800 ULT [EUDAMED]; 10449023 [EUDAMED]; 000000000010449023 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07630003593587 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 76300035FL8007W [EUDAMED]
- FDA product code: IZI [FDA GUDID (AccessGUDID)]
- EMDN code: Z12011199 [EUDAMED]
- GMDN term: Surgical microscope fluorescent angiography system (57883) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.1600 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: FL800 Ult, Leica Microsystems (Schweiz) AG. deviCERTS medical device catalogue. https://devicerts.com/devices/fl800-ult-10449023 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/fl800-ult-10449023.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/fl800-ult-10449023
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.