FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Epic 980
K Number: K192430
·
Decision Dec 4, 2019
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
10
Review Days
90
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Basic Information
- Device Name
- Epic 980
- K Number
- K192430
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biolase, Inc.
- Date Received
- September 5, 2019
- Decision Date
- December 4, 2019
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Biolase, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210183 | Waterlase iPLus | Apr 21, 2022 | Substantially Equivalent |
| K213428 | EdgePro | Dec 22, 2021 | Substantially Equivalent |
| K193486 | Epic 980 | Mar 16, 2020 | Substantially Equivalent |
| K190319 | Waterlase Laser System Family | Oct 10, 2019 | Substantially Equivalent |
| K172771 | Epic Pro 940 | Nov 29, 2017 | Substantially Equivalent |
| K163128 | Epic Pro | Jan 11, 2017 | Substantially Equivalent |
| K161669 | Waterlase Express | Jul 28, 2016 | Substantially Equivalent |
| K141975 | WATERLASE IPLUS S | Mar 5, 2015 | Substantially Equivalent |
| K140120 | EPIC 10 | Oct 10, 2014 | Substantially Equivalent |