IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM
FDA premarket approval P930016/S045 · decided 2016-11-14
Approval details
- PMA number
- P930016
- Supplement
- S045
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2015-06-01
- Decision date
- 2016-11-14
- Days to decision
- 532 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication System is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) for Use: in patients:1) with mixed astigmatism as measured by iDesign Advanced WaveScan Studio System where the magnitude of cylinder (1.0 to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; 2) with agreement between manifest refraction (adjusted for optical infinity)
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510(k) clearances by this applicant
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|---|---|---|
| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
| CATALYS Precision Laser system (K220516) | Amo Manufacturing USA, LLC | 2022-05-17 |
| CATALYS Precision Laser System (K210701) | Amo Manufacturing USA, LLC | 2021-04-07 |
| Catalys Precision Laser System (K182083) | Amo Manufacturing USA, LLC | 2018-11-09 |
| Catalys Precision Laser System (K172002) | Amo Manufacturing USA, LLC | 2017-08-25 |
| IFS ADVANCED FEMTOSECOND LASER SYSTEM (K141852) | Amo Manufacturing USA, LLC | 2015-01-06 |