Identity
- Trade Name
- RxSight Light Adjustable Lens (RxLAL) FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- LAL, Sterile, Packaged, 27.0 Diopter FDA UDI
- Model / Reference
- 60005-3270 FDA UDI
- Description
- LAL, Sterile, Packaged, 27.0 Diopter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818806020784 FDA UDI
- PMA Number
- P160055 FDA UDI
- FDA Product Code
- PZK 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
Yes
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
RxSight Light Adjustable Lens (RxLAL) by Rxsight, 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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Cleared under the same submission
P160055 also covers:
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, INC.
- Light Adjustable Lens (LAL) — RXSIGHT, 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
- Rxsight, Inc.
Sources (1)
- FDA UDI 0dbd5eee-4310-4946-8558-e06843993e5f 35 fields · synced Jun 1, 2026