Identity
- Trade Name
- OPHTHALMIC YAG LASER SYSTEM FDA UDI
- Generic Name
- Ophthalmic solid-state laser system, photodisruption FDA UDI
- Device Name
- The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) pulse beam by Q-switching. The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. The main purposes of the YC-1800 are posterior capsulotomy for secondary cataract, iridotomy for acute angle-closure glaucoma, and for pupillary membranectomy for traction retinal detachment. The YC-1800 has a slit lamp for observation that includes the YAG laser and its controlling mechanism. The YC-1800 is also equipped with an operation panel and knobs that facilitate operation. The compact and lightweight power supply box is installed separately for lightness and compactness of the system. In addition, a motorized table for the YC-1800 is available optionally. FDA UDI
- Model / Reference
- YC-1800 FDA UDI
- Description
- The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) pulse beam by Q-switching. The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. The main purposes of the YC-1800 are posterior capsulotomy for secondary cataract, iridotomy for acute angle-closure glaucoma, and for pupillary membranectomy for traction retinal detachment. The YC-1800 has a slit lamp for observation that includes the YAG laser and its controlling mechanism. The YC-1800 is also equipped with an operation panel and knobs that facilitate operation. The compact and lightweight power supply box is installed separately for lightness and compactness of the system. In addition, a motorized table for the YC-1800 is available optionally. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100073 FDA UDI
- FDA Product Code
- LXS FDA UDI
- GMDN Term
- Ophthalmic solid-state laser system, photodisruption FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4392 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
Yes
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
Ophthalmic Yag Laser System by Nidek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI 8140b06d-277a-4c3c-a4c5-29599119c1f1 34 fields · synced Jun 8, 2026