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Capsulo

by Quantel Medical

510(k) K220430Ref CAPSULO, PABX0052C

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K220430↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03700542625958 Basic UDI-DI 03700542625958UDI-DIDate28 May 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03700542625958 Basic UDI-DI 03700542625958UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700542625958 UDI-DI Date25 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK220430 Date12 May 2022ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03700542625958 registered 28 May 2026 Active· +1 more in the status table
  • FDA 510(k) K220430 decided 12 May 2022 Active
  • FDA GUDID UDI-DI 03700542625958 listed 25 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220430
  2. Listed FDA GUDID 03700542625958
  3. Registered EUDAMED B-03700542625958

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Ophthalmic solid-state laser system
Model / reference
CAPSULO, PABX0052C
Primary DI / UDI-DI
03700542625958
Basic UDI-DI
B-03700542625958, 37005426CAPSULOFB
510(k) Number
FDA product code
HQF
EMDN code
Z12011017, Z12120299
GMDN term
Ophthalmic solid-state laser system
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 886.4390
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Poland
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K220430

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K220430
UDI-DISize and differences
CAPSULO
QUANTEL MEDICAL
CAPSULO03700542625958 —On the market

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Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)