Kiierr 272 Laser, Kiierr 148 Laser
FDA 510(k) clearance K181878 · decided 2018-09-05
Clearance details
- K-number
- K181878
- Device name
- Kiierr 272 Laser, Kiierr 148 Laser
- Applicant
- Kiierr International, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-07-13
- Decision date
- 2018-09-05
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.