STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
FDA premarket approval P930016/S048 · decided 2017-06-30
Approval details
- PMA number
- P930016
- Supplement
- S048
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2016-12-01
- Decision date
- 2017-06-30
- Days to decision
- 211 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 System. The STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System is indicated for Wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: 1) with hyperopia with and without astigmatism as measured by iDesign® Advanced WaveScan Studio System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder;2) with agreement between manifest refraction (adjusted for optical
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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 |