Identity
- Trade Name
- SOFTEC HDO FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear) FDA UDI
- Model / Reference
- SOFTECHDO+21.0 FDA UDI
- Description
- IOL - HEMA - 1pc 6.5x5.75/12.5mm (Oval Aspheric Clear) FDA UDI
Identifiers
- Catalog Number
- SOFTEC HDO FDA UDI
- Primary DI / UDI-DI
- 00844369037396 FDA UDI
- PMA Number
- P090022 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Softec Hdo by Lenstec Barbados Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Posterior-chamber intraocular lens, pseudophakic.
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- TECNIS IOL — Johnson & Johnson Surgical Vision, Inc. · Class III
- enVista Aspire™ Toric IOL — Bausch & Lomb Incorporated · Class III
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Cleared under the same submission
P090022 also covers:
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
- SOFTEC HD PLI — Lenstec Barbados Inc
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
- Lenstec Barbados Inc
Sources (1)
- FDA UDI 3bfad19a-8940-4d9a-9fb8-d0c44dfb277d 38 fields · synced May 30, 2026