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510(k) K242441

Revian Lyte (10011) by Revian, Inc. — Product Code OAP

K242441 is an FDA 510(k) premarket notification submitted by Revian, Inc. for the device "Revian Lyte (10011)". The FDA issued a decision of Substantially Equivalent on September 13, 2024. 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
September 13, 2024
Date Received
August 16, 2024
Clearance Type
Special
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

Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v

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FDA data resources