LASEREX INTEGRE, MODEL LP2532
FDA 510(k) clearance K003955 · decided 2001-03-15
Clearance details
- K-number
- K003955
- Device name
- LASEREX INTEGRE, MODEL LP2532
- Applicant
- Ellex Medical Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-21
- Decision date
- 2001-03-15
- Days to decision
- 84 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
No recalls on record reference this clearance.