FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EdgePro
K Number: K213428
·
Decision Dec 22, 2021
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
10
Review Days
62
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Basic Information
- Device Name
- EdgePro
- K Number
- K213428
- 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
- October 21, 2021
- Decision Date
- December 22, 2021
- Product Code
- NVK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NVK | Laser, Dental, Soft Tissue | 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 |
| K193486 | Epic 980 | Mar 16, 2020 | Substantially Equivalent |
| K192430 | Epic 980 | Dec 4, 2019 | 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 |