510(k) K150212
- Device
- DeScribe Transparent PFD Patch
- Applicant
- ON Light Sciences, Inc.
- 510(k) number
- K150212
- Product code
- PKO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-20
- Date received
- 2015-01-30
- Regulation
- 878.4810
- Classification name
- Transparent Patch For Use In Treatment Of Tattoos
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Sell
- Address
- 7852 Starward Dr. Dublin CA US 94568 94568
FDA Registration Numbers#
- 3011310987
- 2135225
- 3013840437
Source Documents#
Other 510(k) Records For Product Code PKO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172689 | DESCRIBE PFD Patch | Merz North America, Inc. | 2017-11-29 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases