WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)

Wontech Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K241643
Device name
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-06-07
Decision date
2025-02-14
Submission type
Traditional
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Surgical cuttingOtherOtherOther
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

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

Intended Use

WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 532nm - 2200nm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

Device Description

WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R as surgical laser fiber is indicated for use in general surgical applications of incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode with a compatible laser system marketed for use in the desired application. Especially, they are intended for endovascular coagulation of blood vessels. WT-SMA-400(or BA400)/WT-SMA-600(or BA600) is bare-typed fiber and BA400R/BA600R is radial-typed fiber. The shape of distal end of fiber is different between bare and radial fiber. Bare fiber distal end is flat to radiate laser straightly, but radial fiber distal end is conical to radiate laser radially. Additionally, BA400 and BA600 have same design with the each original model(WT-SMA-400 and WT-SMA-600). The additional model name(BA400 and BA600) and each original model name(WT-SMA-400 and WT-SMA-600) need to be alternatively exchanged and labeled depending on customer requirement. WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode and output power less than 30 W. They are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices. They were designed to be connected with laser medical device consisted with SMA905 connector according to IEC 61754-22 and output power less than 30 W.

Summary parsed at:2026-06-01 05:21:09 UTC

Predicate devices

1

K241643 references 1 predicate/reference device

Cited as predicate

2

2 submissions cite K241643 as a predicate