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YAG laser combination delivery unit (YC-200)

FDA UDI

Class II (US FDA UDI)

by Nidek, Inc.

Identity

Trade Name
YAG laser combination delivery unit (YC-200) FDA UDI
Generic Name
Ophthalmic solid-state laser system, photodisruption FDA UDI
Device Name
delivery unit is connected to the laser photocoagulator and YAG laser system to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) or photodisruption using a Nd:YAG laser beam (1064 nm, hereafter referred to as “YAG laser beam”) or SLT laser (532 nm, for YC-200 S plus only) while observing the patient’s eye with the slit lamp. FDA UDI
Model / Reference
17148-K020 FDA UDI
Description
delivery unit is connected to the laser photocoagulator and YAG laser system to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) or photodisruption using a Nd:YAG laser beam (1064 nm, hereafter referred to as “YAG laser beam”) or SLT laser (532 nm, for YC-200 S plus only) while observing the patient’s eye with the slit lamp. FDA UDI

Identifiers

Primary DI / UDI-DI
04987669101650 FDA UDI
FDA Product Code
HQF FDA UDI
HJO FDA UDI
GMDN Term
Ophthalmic solid-state laser system, photodisruption FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4390 FDA UDI
886.1850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic solid-state laser system, photodisruption

YAG laser combination delivery unit (YC-200) by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic solid-state laser system, photodisruption.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nidek, Inc.

Sources (1)

  • FDA UDI bef4481b-0681-477d-b9bd-0c0fb1c45367 33 fields · synced Jun 8, 2026