DOCUMENTING LASER SLIT LAMP, DP 2010
FDA 510(k) clearance K012873 · decided 2001-11-19
Clearance details
- K-number
- K012873
- Device name
- DOCUMENTING LASER SLIT LAMP, DP 2010
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-27
- Decision date
- 2001-11-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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