510(k) K100628
- Device
- PLASMALUXLS
- Applicant
- DAAVLIN DISTRIBUTING CO.
- 510(k) number
- K100628
- Product code
- ONE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-24
- Date received
- 2010-03-05
- Regulation
- 878.4810
- Classification name
- Powered Light Based Non-laser Surgical Instrument
- 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
- MICHELE THIEL
- Address
- 205 W. Bement St. Bryan OH US 43506 43506
FDA Registration Numbers#
- 3013481783
- 3006716777
- 3008442971
- 1526255
Source Documents#
Other 510(k) Records For Product Code ONE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250224 | handLITE (TN19S) | iSMART Developments, Ltd. | 2025-04-18 |
| K171055 | Philips BlueControl | Philips Electronics Nederland B.V. | 2017-07-06 |
| K103415 | TANDA MAX | Pharos Life Corporation | 2011-01-03 |
| K091467 | BABY QUASAR | Silver Bay, LLC | 2010-09-17 |
| K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Verilux | 2010-09-03 |
| K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Led Intellectual Properties, LLC | 2010-02-04 |
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