Identity
- Trade Name
- WAVE ANALYZER MEDICA 700 PLUS FDA UDI
- Generic Name
- Corneal topography system analyser FDA UDI
- Device Name
- The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 technologies : - Shack Hartmann technology : to measure both low and high order aberrations of the eye, to measure refraction. - Placido disks : for keratometry and for corneal topography measurement. - Non-contact tonometer. - Scheimpflug image : for anterior chamber analysis (pachymetry, irido corneal angle). - Retro illumination : for detection of opacity. Measurement is fully automatic using image processing software and fully automated motors for centering and focusing. The machine includes a fixation target with automatic fogging for accommodation control. FDA UDI
- Model / Reference
- WAM700 FDA UDI
- Description
- The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 technologies : - Shack Hartmann technology : to measure both low and high order aberrations of the eye, to measure refraction. - Placido disks : for keratometry and for corneal topography measurement. - Non-contact tonometer. - Scheimpflug image : for anterior chamber analysis (pachymetry, irido corneal angle). - Retro illumination : for detection of opacity. Measurement is fully automatic using image processing software and fully automated motors for centering and focusing. The machine includes a fixation target with automatic fogging for accommodation control. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615020000380 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Corneal topography system analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 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
Yes
FDA UDI
Category: Automated ophthalmic refractometerOphthalmic tonometer, line-poweredCorneal topography systemCorneal topography system analyser
Wave Analyzer Medica 700 Plus by Essilor International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bench-top keratometer.
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- OptochekPlus — REICHERT INC. · Class II
- OPTICAL BIOMETER — SANTEC CORPORATION · Class II
- Visionix — RIGHT MFG. CO., LTD. · Class I
- OPTICAL BIOMETER — Nidek, Inc. · Class II
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
- Essilor International
Sources (1)
- FDA UDI 5045f179-a735-42b0-b255-f9c1ae2f1c40 35 fields · synced May 30, 2026