Identifiers
- 510(k) Number
- K222916 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 US 450 Diode Laser Equipment is a diode laser device intended for use in general and plastic surgery procedures. It is substantially equivalent to predicate devices cleared under the FDA 510(k) process.
The device is supplied by Beijing Globalipl Development Co., Ltd. and has received FDA 510(k) clearance under K number K222916. It is intended for use in clinical settings as indicated by its authorization and device classification.
Frequently asked questions
What is the US 450 Diode Laser Equipment intended for?
The US 450 Diode Laser Equipment is intended for use in general and plastic surgery procedures, as stated in its description. This indication is based on its substantial equivalence to predicate devices cleared under the FDA 510(k) process for those surgical applications.
How is the US 450 Diode Laser Equipment supplied and by whom?
The device is supplied by Beijing Globalipl Development Co., Ltd., the manufacturer listed in the device data. It is provided as a complete diode laser system for clinical use in settings where general and plastic surgery procedures are performed.
What regulatory pathway was used for the US 450 Diode Laser Equipment?
The US 450 Diode Laser Equipment received FDA 510(k) clearance under K number K222916, as indicated in the AUTHORIZATIONS and k_number fields. This means it was cleared through the traditional 510(k) process by demonstrating substantial equivalence to a legally marketed predicate device.
Is the US 450 Diode Laser Equipment described as sterile or single-use in the provided data?
The device data does not specify whether the US 450 Diode Laser Equipment is sterile, single-use, or reusable. No information about sterility, reprocessing, or disposal is included in the specifications or description fields, so these details cannot be inferred from the provided data.
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: K222916 - US 450 Diode Laser Equipment - FDA 510 (k), Globalipl - Professional Aesthetic Machine Supplier, Ipl Machine, Diode Laser Hair Removal Machine, Price, K222916 · Predicate Devices · Benchmed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222916 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Globalipl Development Co., Ltd.
Sources (1)
- FDA 510(k) K222916 24 fields · synced Sep 19, 2026