Chrysalis Intelligence · Sponsors · Bemer Int AG

Bemer Int AG

Triesen, LI · 3 510(k) clearances · 1 recalls

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Total clearances

3

2021-02-04 → 2023-09-23

Last 12 months

0

Product codes

2

Most recent

2023-09-23

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Class II	Physical Medicine	2	2023-06-09
OHS	Light Based Over The Counter Wrinkle Reduction	Class II	General, Plastic Surgery	1	2023-09-23

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

0

Most recent

2021-01-13

Date	Severity	Status	Recall #	Product	Code	Reason
2021-01-13	Class II	Terminated	Z-1105-2021	Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 42010…	—	There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of …

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2023-09-23	K223919	B.Light Clear Evo and B.Light Restore Evo	OHS	Class II	General, Plastic Surgery
2023-06-09	K231368	Bemer Therapy System Evo	NGX	Class II	Physical Medicine
2021-02-04	K210174	BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set	NGX	Class II	Physical Medicine