Identity
- Trade Name
- Final Fit™ FDA UDI
- Generic Name
- Ophthalmic excimer laser system FDA UDI
- Device Name
- The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data) FDA UDI
- Model / Reference
- 1.11US FDA UDI
- Description
- The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100035 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic excimer laser system
Final Fit™ by Nidek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic excimer laser system.
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- 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 a7bb3b2c-e289-430e-b2bf-c97d419bda07 34 fields · synced May 30, 2026