Apollo V+ Medical Platform, Apollo Iv+ Medical Platform, Nice Station Light Bas…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113018

Identifiers

510(k) Number: K113018 FDA 510(k)
FDA Product Code: GEX 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)

Apollo V+ Medical Platform, Apollo Iv+ Medical Platform, Nice Station Light Bas… by Beijing Syntech Laser Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K113018	Class II	Active

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Manufacturer

Manufacturer: Beijing Syntech Laser Co., Ltd.

Sources (1)

FDA 510(k) K113018 24 fields · synced Jun 18, 2026