Identity
- Trade Name
- IPure FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use. FDA UDI
- Model / Reference
- B1PY (yellow), +10.00D FDA UDI
- Description
- Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886158017493 FDA UDI
- FDA Product Code
- HQL FDA UDI
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
IPure by Hoya Medical Singapore Pte. Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Posterior-chamber intraocular lens, pseudophakic.
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- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
- ISOTECHNICS — EYEKON MEDICAL, INC. · Class III
- TECNIS IOL — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista Aspire™ Toric IOL — Bausch & Lomb Incorporated · Class III
- TECNIS SIMPLICITY — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista® Toric IOL — Bausch & Lomb Incorporated · 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
- Hoya Medical Singapore Pte. Ltd.
Sources (1)
- FDA UDI 37b68104-98a5-4807-b20a-f1cc0a33f2e1 33 fields · synced Jun 8, 2026