LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
FDA 510(k) clearance K052777 · decided 2006-03-16
Clearance details
- K-number
- K052777
- Device name
- LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
- Applicant
- Ellex Medical Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-03
- Decision date
- 2006-03-16
- Days to decision
- 164 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
- Adelaide, South Australia, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S recall (Z-0287-2008) | Ellex USA | 2007-12-20 |