Product areas
FDA product code distribution
Bios S.R.L.
Country / region:Italy (IT)
510(k) submissions
4
Filtered: GEX
Latest clearance
2024-12-30
Product codes
1
GEX
510(k) submissions
4 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | GEX | Class 2 | 2024-12-30 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | GEX | Class 2 | 2024-06-14 |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | GEX | Class 2 | 2016-12-08 |
| K153229 | Superbium | GEX | Class 2 | 2016-04-12 |
Company profile
- Canonical name
- Bios S.R.L.
- Country
- Italy(IT)
Cited predicates
11- K161632
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
- K201111
GentleMax Pro Plus
- K140122
—
—
Not ingested - K150516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
- K072344
—
—
Not ingested - K072564
—
—
Not ingested - K090195
—
—
Not ingested - K103664
—
—
Not ingested - K111303
—
—
Not ingested - K111360
—
—
Not ingested - K150140
MCL 31 Dermablate
Bios S.R.L. references 11 predicate/reference devices