510(k) K211192
K211192 is an FDA 510(k) premarket notification submitted by Leana Orders, Inc. for the device "Grivamax Family of Lasers, Models 272 and 148". The FDA issued a decision of Substantially Equivalent on Jul 20, 2021. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Leana Orders, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 20, 2021
- Date Received
- Apr 21, 2021
- 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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