Portable Slit Lamp
FDA 510(k) clearance K153545 · decided 2016-06-22
Clearance details
- K-number
- K153545
- Device name
- Portable Slit Lamp
- Applicant
- Shanghai Bolan Optical-Electric Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-11
- Decision date
- 2016-06-22
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- HJO
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.