Ophthalmic Yag Laser System Yc-200

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref B01E006Model YC-200510(k) K192045

by NIDEK.CO.Ltd.,

Identity

Trade Name: OPHTHALMIC YAG LASER SYSTEM YC-200 EUDAMED
Ophthalmic YAG Laser System FDA UDI
Generic Name: Ophthalmic solid-state laser system, photodisruption FDA UDI
Device Name: The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy. FDA UDI
Model / Reference: YC-200 EUDAMEDFDA UDI
B01E006 EUDAMED
Description: The OPHTHALMIC YAG LASER SYSTEM YC-200 is an ophthalmic pulsed-laser system consisting of a main body containing the laser, a head rest, a control box, and a connector box. The device uses a 1,064 nm pulsed Nd: YAG laser as the treatment beam source. Laser pulses are generated using a method called passive Q-switching. With this method, short high-power pulses can be emitted. At the target, the emitted pulses cause photodisruption, which is fragmentation of tissue using light energy. FDA UDI

Identifiers

Primary DI / UDI-DI: 04987669101452 EUDAMEDFDA UDI
Basic UDI-DI: 4987669219GM EUDAMED
FDA Product Code: HQF FDA UDI
HJO FDA UDI
EMDN Code: Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
GMDN Term: Ophthalmic solid-state laser system, photodisruption FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 886.4390 FDA UDI
886.1850 FDA UDI
Market of Registration: Germany EUDAMED
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

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

Ophthalmic Yag Laser System Yc-200 by Nidek Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K203130	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K192045	Class IIb	Active
EUDAMED	European Union	CE/MDR	4987669219GM	Class IIb	Active

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Manufacturer

Manufacturer: NIDEK.CO.Ltd.,
EUDAMED SRN: JP-MF-000040151
FDA Applicant: Nidek Co., Ltd.
Authorised Representative: NIDEK SA FR-AR-000000341

Sources (3)

EUDAMED 392470d8-4a9c-405e-b757-7d3e41c8b311 85 fields · synced Jun 18, 2026
FDA UDI f163362f-1b11-4d31-bfed-eb037c9089ea 34 fields · synced May 30, 2026
FDA 510(k) K203130 1 fields · synced May 18, 2026