Fibercure
FDA 510(k) clearance K232076 · decided 2023-11-02
Clearance details
- K-number
- K232076
- Device name
- Fibercure
- Applicant
- Lumendo AG
- Decision
- Substantially Equivalent
- Date received
- 2023-07-13
- Decision date
- 2023-11-02
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- QNF
- Device class
- 2
- Regulation number
- 872.6070
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Renens, CH
- 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 |
|---|---|---|
| Monet Curing Laser (K201904) | CAO Group, Inc. | 2020-11-24 |
Recalls involving this device
No recalls on record reference this clearance.