Product areas
FDA product code distribution
Biolase, Inc.
Country / region:United States (US)
510(k) submissions
8
Filtered: GEX
Latest clearance
2022-04-21
Product codes
1
GEX
510(k) submissions
8 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K210183 | Waterlase iPLus | GEX | Class 2 | 2022-04-21 |
| K193486 | Epic 980 | GEX | Class 2 | 2020-03-16 |
| K192430 | Epic 980 | GEX | Class 2 | 2019-12-04 |
| K190319 | Waterlase Laser System Family | GEX | Class 2 | 2019-10-10 |
| K172771 | Epic Pro 940 | GEX | Class 2 | 2017-11-29 |
| K163128 | Epic Pro | GEX | Class 2 | 2017-01-11 |
| K161669 | Waterlase Express | GEX | Class 2 | 2016-07-28 |
| K141975 | WATERLASE IPLUS S | GEX | Class 2 | 2015-03-05 |
Company profile
- Canonical name
- Biolase, Inc.
- Country
- United States(US)
Cited predicates
22- K132806
—
—
Not ingested - K141975
WATERLASE IPLUS S
- K080530
—
—
Not ingested - K082445
—
—
Not ingested - K100474
—
—
Not ingested - K103753
—
—
Not ingested - K152032
ELUMI 810 + 980 Soft Tissue Laser
- K192430
Epic 980
- K163128
Epic Pro
- K170500
SIROLaser Advance+
- K121286
—
—
Not ingested - K161669
Waterlase Express
- K101658
—
—
Not ingested - K163128
Epic Pro
- K111689
—
—
Not ingested - K101658
—
—
Not ingested - K052354
—
—
Not ingested - K060033
—
—
Not ingested - K071734
—
—
Not ingested - K101658
—
—
Not ingested - K122368
—
—
Not ingested - K971843
—
—
Not ingested
Biolase, Inc. references 22 predicate/reference devices