Picosecond Nd:YAG Laser Systems (Model HS-298)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K260017

by Shanghai Apolo Medical Technology Co., Ltd

Identifiers

510(k) Number: K260017 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)

The Picosecond Nd:YAG Laser Systems (Model HS-298) is a laser surgical instrument designed for use in general and plastic surgery. It employs picosecond pulse technology to deliver ultra-short laser bursts, targeting precise tissue interaction for procedures such as tattoo removal and skin toning.

This device is supplied as a reusable medical instrument and is classified under 21 CFR 878.4810 for laser surgical applications. It has received FDA 510(k) clearance and MDD compliance, with regulatory submissions filed under product code GEX. The system operates within the parameters of its intended surgical settings, adhering to established safety and performance standards for picosecond laser technology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Picosecond Nd:YAG Laser Systems (Model: HS-298) (K260017) — FDA 510 (k ..., China Picosecond ND YAG Laser HS-298 Manufacturer and Supplier | Apolo ..., Vertical Comfortable Skin Toning Picosecond Nd Yag Laser

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K260017	Class II	Active

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Manufacturer

Manufacturer: Shanghai Apolo Medical Technology Co., Ltd
FDA Applicant: Shanghai Apolo Medical Technology Co., Ltd.

Sources (2)

FDA 510(k) K260017 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 18, 2026