Definition: The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulga
| Device Type ID | 5812 |
| Device Name | Over-the-counter Powered Light Based Laser For Acne |
| Physical State | Light Source |
| Technical Method | The Outputs Are Pre-tuned To A Particular Wavelength With A Narrow Spectral Bandwidth. |
| Target Area | Mainly On The Face, But Can Be On The Back Or On The Other Parts Of The Body. Treatment Area Is 5x6 Cm (at A Time.) |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5812 |
| Device | Over-the-counter Powered Light Based Laser For Acne |
| Product Code | OLP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| CFR Regulation Number | 878.4810 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCORD MEDIA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIORENEW LABS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JOHNSON & JOHNSON CONSUMER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LED INTELLECTUAL PROPERTIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LED TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NUTRA LUXE MD, LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
PULSADERM LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRIA BEAUTY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UPLEVITY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Overheating Of Device | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Accord Media, LLC | II | Mar-01-2018 |