Crystal Vision
FDA 510(k) clearance K163659 · decided 2017-10-30
Clearance details
- K-number
- K163659
- Device name
- Crystal Vision
- Applicant
- I.C Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-27
- Decision date
- 2017-10-30
- Days to decision
- 307 days
- Clearance type
- Special
- Product code
- FYD
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.