Identity
- Trade Name
- SOFTEC HDM FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision) FDA UDI
- Model / Reference
- SOFTECHDM+20.0 FDA UDISOFTECHDM+25.5 FDA UDISOFTECHDM+17.0 FDA UDISOFTECHDM+29.5 FDA UDISOFTECHDM+19.75 FDA UDISOFTECHDM+27.5 FDA UDISOFTECHDM+26.5 FDA UDISOFTECHDM+19.25 FDA UDI
- Description
- IOL - HEMA - 1pc 5.75/12.0mm (Aspheric Clear Micro Incision) FDA UDI
Identifiers
- Catalog Number
- SOFTEC HDM FDA UDI
- Primary DI / UDI-DI
- 00844369039307 FDA UDI00844369039512 FDA UDI00844369039185 FDA UDI00844369039598 FDA UDI00844369039291 FDA UDI00844369039550 FDA UDI00844369039536 FDA UDI00844369039277 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 Hdm by Lenstec Barbados Inc — 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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- 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
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 (8)
- FDA UDI 6d6cc6fb-6ac8-4dc2-9fcc-df29a72cd25f 38 fields · synced Jun 8, 2026
- FDA UDI ef88a7c6-3aa8-439d-bae3-c95b2f06933f 38 fields · synced May 24, 2026
- FDA UDI baf47e5e-a1c1-49da-9f01-da810eadbe34 38 fields · synced May 24, 2026
- FDA UDI 86823230-408a-4ecb-bf6f-eb769a8572b3 38 fields · synced May 25, 2026
- FDA UDI 9a19d57d-79e1-4dd8-a2d0-4dac215c69ab 38 fields · synced May 25, 2026
- FDA UDI 55da4dcb-200b-4d04-a1f2-304241029152 38 fields · synced May 25, 2026
- FDA UDI 9f8d8951-cee0-4987-9f7d-8ea175ebe7a0 38 fields · synced May 25, 2026
- FDA UDI f6df4983-2a9d-4fa5-bdd9-b4bb4d1d419b 38 fields · synced May 27, 2026