Identity
- Trade Name
- Icare ic100 FDA UDI
- Generic Name
- Ophthalmic tonometer, battery-operated FDA UDI
- Device Name
- The Icare ic100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. FDA UDI
- Model / Reference
- TA011 FDA UDI
- Description
- The Icare ic100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic. The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430033850473 FDA UDI
- 510(k) Number
- K153694 FDA UDI
- FDA Product Code
- HKX FDA UDIHKY FDA UDI
- GMDN Term
- Ophthalmic tonometer, battery-operated 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
Yes
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 tonometer, battery-operated
Icare ic100 by Icare Finland Oy — 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
- Icare Finland Oy
Sources (1)
- FDA UDI aed7b52c-2b4a-4f82-8452-aa59bc9e0c46 34 fields · synced Jun 8, 2026