Capsulo
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- CAPSULO EUDAMEDFDA UDI
- Generic Name
- Ophthalmic solid-state laser system FDA UDI
- Device Name
- CAPSULO EUDAMEDCapsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of the posterior capsule of the eye (posterior capsulotomy) and discission of pupillary membranes (pupillary memebranectomy) in aphakic and pseudophakic patients, and irriditomy. FDA UDI
- Model / Reference
- CAPSULO EUDAMEDFDA UDI
- Description
- Capsulo is indicated for photodisruption of ocular tissue using light energy emitted by a Nd. Yag laser, including discission of the posterior capsule of the eye (posterior capsulotomy) and discission of pupillary membranes (pupillary memebranectomy) in aphakic and pseudophakic patients, and irriditomy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700542625958 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700542625958 EUDAMED
- 510(k) Number
- FDA Product Code
- HQF FDA 510(k)FDA UDI
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
- GMDN Term
- Ophthalmic solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)FDA UDI
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
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.
Frequently asked questions
What clinical procedures is the Capsulo Nd:YAG Laser specifically designed to perform in ophthalmology?
The Capsulo Nd:YAG Laser is designed for two key ophthalmic procedures: capsulotomies and iridotomies. Capsulotomies involve creating an opening in the posterior capsule of the lens to address posterior capsule opacification, which can impair vision after cataract surgery. Iridotomies involve opening a small channel in the iris to relieve angle-closure glaucoma by improving aqueous humor flow.
How is the Capsulo device supplied, and what are the requirements for its use in a clinical setting?
The Capsulo Nd:YAG Laser is supplied as a reusable medical instrument, meaning it is intended for multiple uses in clinical settings. Since it is reusable, it must be properly sterilized and maintained according to the manufacturer’s guidelines to ensure safety and efficacy. It is typically integrated with slit-lamp systems for precise ophthalmic procedures.
What regulatory pathways has the Capsulo Nd:YAG Laser followed, and what classification does it hold?
The Capsulo Nd:YAG Laser has obtained FDA 510(k) clearance, demonstrating it is considered substantially equivalent to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) and is classified as a Class II device, indicating moderate risk and requiring specific regulatory controls.
Is the Capsulo device intended for single-use or repeated use, and how does this affect its handling?
The Capsulo Nd:YAG Laser is explicitly designed for repeated use, as it is classified as a reusable medical instrument. This means it requires thorough sterilization between procedures to prevent cross-contamination and maintain its performance. Proper cleaning, sterilization, and maintenance protocols must be followed as outlined by the manufacturer.
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: Ophthalmic laser - CAPSULO - Quantel Medical - Ophthalmology - retinal ..., CAPSULO: new ND:YAG laser by Lumibird Medical, PDF capsula® TM TECHNICAL SPECIFICATIONS - simovision.be, CAPSULO, Capsulotomy and Iridotomy - YouTube, Quantel Medical - Lumibird Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220430 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantel Medical
Sources (3)
- FDA 510(k) K220430 24 fields · synced Sep 18, 2026
- FDA UDI 1fed8b4c-8c70-480e-bb8b-8e357e58e74d 34 fields · synced May 29, 2026
- EUDAMED 8cd07770-c0b3-4279-91e9-07d119382245 61 fields · synced Jul 12, 2026