ORBSCAN
FDA 510(k) clearance K984443 · decided 1999-03-05
Clearance details
- K-number
- K984443
- Device name
- ORBSCAN
- Applicant
- Technolas Perfect Vision GmbH
- Decision
- Substantially Equivalent
- Date received
- 1998-12-14
- Decision date
- 1999-03-05
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- MXK
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Anaheim Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TENEO 317 Model 2 (P990027/S025) | Technolas Perfect Vision GmbH | 2025-02-06 |
| TENEO 317 Model 2 (P990027/S023) | Technolas Perfect Vision GmbH | 2025-02-04 |
| TENEO 317 Model 2 (P990027/S024) | Technolas Perfect Vision GmbH | 2024-12-16 |
| TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) (P990027/S022) | Technolas Perfect Vision GmbH | 2024-11-06 |
| TECHNOLAS TENEO 317 (MODEL 2) Excimer Laser System (P990027/S021) | Technolas Perfect Vision GmbH | 2023-11-22 |
| TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI (P990027/S020) | Technolas Perfect Vision GmbH | 2015-11-05 |
| TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS (P990027/S019) | Technolas Perfect Vision GmbH | 2014-02-27 |
| TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM (P990027/S018) | Technolas Perfect Vision GmbH | 2013-05-17 |