RxSight Light Delivery Device (LDD)
FDA UDIEUDAMEDClass III (US FDA UDI)
Identity
- Trade Name
- Light Delivery Device EUDAMEDRxSight Light Delivery Device (LDD) FDA UDI
- Generic Name
- Ophthalmic examination slit lamp FDA UDI
- Device Name
- Light Delivery Device EUDAMEDFDA UDI
- Model / Reference
- 61002-007 EUDAMED61002 FDA UDI
- Description
- Light Delivery Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818806021002 EUDAMED00818806020029 FDA UDI
- Basic UDI-DI
- 0818806020028H EUDAMED
- PMA Number
- P160055 FDA UDI
- FDA Product Code
- PZK FDA UDI
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic examination slit lamp FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Ophthalmic examination slit lamp
RxSight Light Delivery Device (LDD) by Rxsight, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic examination slit lamp.
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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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Rxsight, Inc.
Sources (2)
- FDA UDI 646cda7e-c886-4ea0-8a5d-f6183fbe346c 34 fields · synced Jul 27, 2026
- EUDAMED b99c7cbc-31a6-478a-8974-a7aa0b7ba0dc 61 fields · synced Jul 27, 2026