Luminopia One
FDA 510(k) clearance DEN210005 · decided 2021-10-20
Clearance details
- K-number
- DEN210005
- Device name
- Luminopia One
- Applicant
- Luminopia, Inc.
- Decision
- Unknown
- Date received
- 2021-03-01
- Decision date
- 2021-10-20
- Days to decision
- 233 days
- Clearance type
- Direct
- Product code
- QQU
- Device class
- 2
- Regulation number
- 886.5500
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Luminopia (K243819) | Luminopia, Inc. | 2025-04-09 |
| Luminopia (K233720) | Luminopia, Inc. | 2024-08-08 |
| Luminopia One (K221659) | Luminopia, Inc. | 2022-11-04 |
| CureSight-CS100 (K221375) | Novasight , Ltd. | 2022-09-29 |
Recalls involving this device
No recalls on record reference this clearance.