510(k) K181878
K181878 is an FDA 510(k) premarket notification submitted by Kiierr International, LLC for the device "Kiierr 272 Laser, Kiierr 148 Laser". The FDA issued a decision of Substantially Equivalent on Sep 5, 2018. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 5, 2018
- Date Received
- Jul 13, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Comb, Hair
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
- 510(k)
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