Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
QPE is the FDA product code for Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions, a class II device type, regulated under 21 CFR 878.4880. FDA's definition for this code reads: "This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QPE
- Device name
- Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
- FDA definition
- This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.
- Regulation
- 21 CFR 878.4880
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QPE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
Applicants with the most clearances
Product code QPE| Applicant | Clearances |
|---|---|
| Klox Technlogies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QPE.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.