Manufacturer
Compex, Spol, S.R.O.JETT Medical II
Country / Region:Czechia (CZ)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240311
- Device name
- JETT Medical II
- Company
- Compex, Spol, S.R.O.
- 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
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K240311 references 1 predicate/reference device
Cited as predicate
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