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Diode Laser Hair Removal (LHR-V6S-1064 +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232117

by Wuhan Lotuxs Technology Co., Ltd.

Identifiers

510(k) Number
K232117 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
LHR-V6S-1064 FDA 510(k)
LHR-V6S FDA 510(k)
B-1064 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Diode Laser Hair Removal (LHR-V6S-1064 +2 more) by Wuhan Lotuxs Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K232117 24 fields · synced Jun 18, 2026