Medical Device Division · registration 241122ActiveAMO Manufacturing USA, LLC.
Hong KongLasers, Femtosecond PulseClass IIIAMO Manufacturing USA, LLC.
Official record identity
- MDACS listing number
- 241122
- Model name
- ELITA Femtosecond Laser System (0155-1001), ELITA Patient Interface (20-pack) (0155-1825), ELITA Patient Interface (1-pack) (0155-2030)
- Registration date
- October 16, 2024
- Expiry date
- October 15, 2029
- Source update date
- September 17, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- AMO Asia Limited
- Manufacturer
- AMO Manufacturing USA, LLC.
Official description
Lasers, Femtosecond Pulse
Additional source fields
- AMD nomenclature code
- 28161
- Traditional Chinese local responsible person
- 眼力健亞洲有限公司
- Local responsible person phone
- 24803330
- Published manufacturer address
- 510 Cottonwood Drive, Milpitas, California 95035 United States
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.