iDESIGNRefractive Studio, STAR Excimer Laser System
FDA premarket approval P930016/S053 · decided 2018-06-15
Approval details
- PMA number
- P930016
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- iDESIGNRefractive Studio, STAR Excimer Laser System
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2017-09-29
- Decision date
- 2018-06-15
- Days to decision
- 259 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- Approval to upgrade the software and hardware to its combined corneal topographer and wavefront aberrometry device, the iDesign Advanced WaveScan Studio System, and expansion of the indications for use of the iDesign system, in combination with the STAR S4 IR Excimer Laser Systems, to include the monovision treatment of myopic presbyopes. The device, as modified, will be marketed under the trade name iDesign Refractive Studio, STAR Excimer Laser System and is indicated for wavefront-guided laser
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |