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JETT Medical II

Compex, Spol, S.R.O.

Country / Region:Czechia (CZ)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Company

Czechia (CZ)

Product code

GEI
21 CFR 878.4400

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240311
Device name
JETT Medical II
Country / Region
Czechia(CZ)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2024-02-02
Decision date
2025-01-22
Submission type
Traditional

Indications for Use

JETT Medical II is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.

Intended Use

JETT Medical II is intended for non‐ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I‐IV.

Device Description

JETT Medical II is a portable medical device designed for non‐ablative treatment of wrinkles and rhytids. The device works on the physical principle of a sequence of DC microcurrents, which are generated by electrically or battery powered generator and that are transmitted to the patient skin through indifferent conductive gel. Patient loop is formed by pairing the handpiece with one of flat applicators with the grounding electrode (cylinder or disposable). Device consists of the standard package and optional accessories: Standard package includes the device itself (dimensions: 275 x 100 x 183 mm) containing Generator and control console, Pen III, Flat applicators (3 mm, 5 mm, 10 mm, 20 mm), Cylinder electrode, Disposable electrode, Curly connection cable for disposable electrodes, Connection cable for cylinder electrode, Extension cable for power supply, Power supply unit, Foot switch, Rechargeable battery. Optional accessories include Pen III/S and additional Flat applicators (3 mm S, 5 mm S, 10 mm S, 20 mm S).

Summary parsed at:2026-06-20 17:44:59 UTC

Predicate devices

1

K240311 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K240311 as a predicate