PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
FDA 510(k) clearance K070270 · decided 2007-11-05
Clearance details
- K-number
- K070270
- Device name
- PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
- Applicant
- Kirchner & Wilhelm GmbH + Co.Kg
- Decision
- Substantially Equivalent
- Date received
- 2007-01-29
- Decision date
- 2007-11-05
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- HLJ
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.