FDA Registration
Active
🇺🇸 United States
RxSight Inc.
Reg #: 3012712027
·
FEI: 3012712027
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- RxSight Inc.
- Registration Number
- 3012712027
- FEI Number
- 3012712027
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Columbia
- City
- Aliso Viejo
- State
- CA
- ZIP
- 92656
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231838
- PMA Number
- P160055
Owner / Operator
- Firm Name
- RxSight Inc.
- Operator Number
- 10028051
- Address
- 100 Columbia
- City
- Aliso Viejo
- State
- CA
- Postal Code
- 92656
- Country
- US
- Correspondent
- Debe Deck
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2023-10-25 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2023-05-20 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2020-10-05 |
| Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) | PZK | Class 3 | Ophthalmic | No | 2017-11-27 |
Proprietary Names
RxSight Insertion Device
Contrast Card
RxSight Contact Lens
RxSigfht Injector Cartridge and RxSight Injector Handpiece
RxSight Light Delivery Device (LDD)
RxSight Light Adjustable Lens (LAL+)
RxSight Post Operative Spectacles
RxSight Light Adjustable Lens (RxLAL)
Establishment Types
Manufacture Medical Device