Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)

Micro-Energy Medical Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

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0

Device details

FDA 510(k) registration fields

K number
K252745
Device name
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-08-29
Decision date
2025-12-12
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingVascular treatmentOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Halo Sterile Single-use Radial Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Halo Sterile Single-use Radial Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

Intended Use

Halo Sterile Single-use Radial Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Halo Sterile Single-use Radial Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

Device Description

The Halo Sterile Single-use Radial Fibers (Model: Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8), as surgical laser fibers, are suitable for use in combination with commercially available diode laser systems with a wavelength ranging from 500nm to 2200nm and equipped with SMA905 connectors. The output power should not exceed 30 W. This device is single use only and sterilized by EO gas. The Halo Sterile Single-use Radial Fibers are intended for general surgical operations such as incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissues in either contact or non-contact mode. In particular, they are designed for endovascular coagulation of blood vessels. The Fiber is radial-typed fiber. The shape of distal end of fiber is conical to radiate laser radially.

Summary parsed at:2026-06-01 05:24:14 UTC

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