Identity
- Trade Name
- Quest™ FDA UDI
- Generic Name
- Ophthalmic excimer laser system FDA UDI
- Device Name
- NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology. FDA UDI
- Model / Reference
- EC-5000 FDA UDI
- Description
- NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model Quest, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system, and a computer for system control. The system is designed to be user friendly for easy and safe operation with NIDEK’s advanced optoelectronic technology. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100028 FDA UDI
- FDA Product Code
- LZS FDA UDI
- GMDN Term
- Ophthalmic excimer laser system FDA UDI
Classification
- Device Class
- Class III 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 excimer laser system
Quest™ by Nidek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic excimer laser system.
- WAVELIGHT EX500 EXCIMER LASER — Alcon Laboratories, Inc. · Class III
- MEL 90 — Carl Zeiss Meditec AG · Class III
- MEL 80 — Carl Zeiss Meditec AG · Class III
- STAR S4 IR — Johnson & Johnson Surgical Vision, Inc. · Class III
- Final Fit™ — Nidek, Inc. · Class III
- Final Fit™ — Nidek, Inc. · Class III
- Final Fit — Nidek, Inc. · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI ee2c5755-fa5e-466c-84c5-b1bc7fbb350a 34 fields · synced May 30, 2026