IFS ADVANCED FEMTOSECOND LASER SYSTEM
FDA 510(k) clearance K141852 · decided 2015-01-06
Clearance details
- K-number
- K141852
- Device name
- IFS ADVANCED FEMTOSECOND LASER SYSTEM
- Applicant
- Amo Manufacturing USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-07-09
- Decision date
- 2015-01-06
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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