FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
reVive Light Therapy Essentials
K Number: K210965
·
Decision Dec 15, 2021
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
12
Review Days
259
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Basic Information
- Device Name
- reVive Light Therapy Essentials
- K Number
- K210965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Led Technologies, Inc.
- Date Received
- March 31, 2021
- Decision Date
- December 15, 2021
- Product Code
- OHS
- 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 |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Led Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | Dec 21, 2022 | Substantially Equivalent |
| K221430 | reVive Light Therapy LED Cleansing System | Jul 27, 2022 | Substantially Equivalent |
| K210968 | reVive Light Therapy Essentials | Dec 21, 2021 | Substantially Equivalent |
| K183247 | dpl Faceware | Mar 14, 2019 | Substantially Equivalent |
| K183118 | dpl SpotLite | Feb 7, 2019 | Substantially Equivalent |
| K180447 | reVive Light Therapy LED Cleansing System | Jun 4, 2018 | Substantially Equivalent |
| K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System | May 15, 2018 | Substantially Equivalent |
| K180320 | dpl IIa Panel | Apr 3, 2018 | Substantially Equivalent |
| K172662 | reVive Perioral | Jan 9, 2018 | Substantially Equivalent |
| K171386 | dpl SpectraLite | Aug 7, 2017 | Substantially Equivalent |