# Capsulo

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

- Canonical page: <https://devicerts.com/devices/capsulo-hqf>
- Manufacturer: [Quantel Medical](https://devicerts.com/manufacturers/quantel-medical) (FDA registration: France)
- Device class: Class IIb (EU MDR / EU MDD); Class II (US FDA)
- FDA product code: HQF
- EMDN: Z12011017 NEODYMIUM SURGICAL LASER
- EMDN: Z12120299 THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
- GMDN: Ophthalmic solid-state laser system (62197)

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Capsulo Nd:YAG Laser is an ophthalmic laser device designed for performing capsulotomies and iridotomies. It employs neodymium-doped yttrium aluminium garnet (Nd:YAG) laser technology to precisely cut or open the posterior capsule of the lens or the iris, addressing conditions such as posterior capsule opacification or angle-closure glaucoma.

This device is intended for use in clinical ophthalmology settings, typically integrated with slit-lamp systems. It is supplied as a reusable medical instrument and requires proper sterilization and maintenance per manufacturer guidelines. The device holds FDA 510(k) clearance and complies with the Medical Device Directive (MDD), with regulatory classification as a Class II device. No specific sterility or single-use designation is stated in the provided data.

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI B-03700542625958 · UDI-DI 03700542625958 · registered 2026-05-28 · status: Active
- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-03700542625958 · UDI-DI 03700542625958 · registered 2026-05-28 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 03700542625958 · listed 2025-03-25 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K220430 · decision 2022-05-12 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Ophthalmic solid-state laser system [FDA GUDID (AccessGUDID)]
- Model / reference: CAPSULO [EUDAMED, FDA GUDID (AccessGUDID)]; PABX0052C [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 03700542625958 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-03700542625958 [EUDAMED]; 37005426CAPSULOFB [EUDAMED]
- 510(k) Number: K220430 [FDA 510(k), FDA GUDID (AccessGUDID)]
- FDA product code: HQF [FDA 510(k), FDA GUDID (AccessGUDID)]
- EMDN code: Z12011017 [EUDAMED]; Z12120299 [EUDAMED]
- GMDN term: Ophthalmic solid-state laser system (62197) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA 510(k), FDA GUDID (AccessGUDID)]
- Regulation: 21 CFR Part 886.4390 [FDA 510(k), FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]; Standard device [EUDAMED]
- EU market of registration: Poland [EUDAMED]
- Advisory committee: Ophthalmic [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- 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]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- 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: Capsulo, Quantel Medical. deviCERTS medical device catalogue. https://devicerts.com/devices/capsulo-hqf (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/capsulo-hqf.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/capsulo-hqf
- 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.