GDXPRO
FDA 510(k) clearance K093521 · decided 2009-11-25
Clearance details
- K-number
- K093521
- Device name
- GDXPRO
- Applicant
- Carl Zeiss Meditec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-13
- Decision date
- 2009-11-25
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- MYC
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Dublin, CA, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| OcuMet Beacon (OCUB100) (K241931) | Ocusciences, Inc. | 2025-04-22 |
| MAIA (AHMACME001) (K243504) | Centervue S.P.A. | 2025-03-17 |
| DRSplus (K213705) | Centervue S.P.A. | 2021-12-21 |
| EIDON FA, EIDON, EIDON AF, EIDON UWFL (K211328) | Centervue S.P.A. | 2021-08-19 |
| DRSplus (K192113) | Centervue S.P.A. | 2019-11-15 |
| EIDON FA (K180526) | Centervue S.P.A. | 2018-07-16 |
| Retia 2 (K180293) | Centervue S.P.A. | 2018-05-30 |
| MAIA (K153181) | Centervue S.P.A. | 2016-06-08 |
| COMPASS (K150320) | Centervue S.P.A. | 2015-06-30 |
| P200DTx (K142897) | Optos Plc. | 2015-01-16 |
| EIDON (K142047) | Centervue S.P.A. | 2014-11-12 |
| DAYTONA ICG (P200TICG) (K134039) | Optos Plc. | 2014-04-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VisuMax; VISUMAX 800 (P150040/S020) | Carl Zeiss Meditec, Inc. | 2025-12-18 |
| VISUMAX 800 Femtosecond Laser (P150040/S023) | Carl Zeiss Meditec, Inc. | 2025-10-16 |
| Visumax; VISUMAX 800 (P150040/S021) | Carl Zeiss Meditec, Inc. | 2025-08-21 |
| MEL 90 EXCIMER LASER SYSTEM (P060004/S009) | Carl Zeiss Meditec, Inc. | 2025-05-23 |
| MEL90 (P060004/S006) | Carl Zeiss Meditec, Inc. | 2024-12-04 |
| VisuMax Femtosecond Laser (P150040/S018) | Carl Zeiss Meditec, Inc. | 2024-10-16 |
| VisuMax (P150040/S016) | Carl Zeiss Meditec, Inc. | 2024-10-11 |
| VisuMax (P150040/S017) | Carl Zeiss Meditec, Inc. | 2024-05-23 |