Identity
- Trade Name
- Reichert® 7 Auto Tonometer FDA UDI
- Generic Name
- Ophthalmic tonometer, line-powered FDA UDI
- Device Name
- AC powered, non-contact tonometer indicated for measuring intraocular pressure to aid in the screening and diagnosis of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement. FDA UDI
- Model / Reference
- 16050 FDA UDI
- Description
- AC powered, non-contact tonometer indicated for measuring intraocular pressure to aid in the screening and diagnosis of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559010177 FDA UDI
- 510(k) Number
- K990869 FDA UDI
- FDA Product Code
- HKX FDA UDI
- GMDN Term
- Ophthalmic tonometer, line-powered 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: Ophthalmic tonometer, line-powered
Reichert® 7 Auto Tonometer by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic tonometer, line-powered.
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- AUTO REF/KERATO/TONOMETER — Nidek, Inc. · Class II
- Falck Medical Multi-Function Applanation Tonometer — Falck Medical, Inc. · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- Eli Ezer — U.S. OPHTHALMIC, L.L.C. · Class II
- WAVE ANALYZER MEDICA 800 — ESSILOR INTERNATIONAL · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
- NON-CONTACT TONOMETER — Tomey Corporation · Class II
Cleared under the same submission
K990869 also covers:
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
- Reichert Inc.
Sources (1)
- FDA UDI ce5e5d73-c284-4ff4-83af-1bb1637a3a86 35 fields · synced Jun 1, 2026