Definition: Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
| Device Type ID | 5799 |
| Device Name | Light Based Over The Counter Wrinkle Reduction |
| Physical State | The Device Can Be Hand Held Or Mounted On A Support System Like A Stand Or Mechanical Arm. The Device Will Emit Light That Can Be Monochromatic Or Narrow Band Or Broad Band. The Light Energy May Be Very Low To Moderate Power Levels. |
| Technical Method | Uses Light Based Energy Delivered To And Or Through The Skin To Effect Change In The Tissue That Results In The Reduction Of Wrinkles. |
| Target Area | Mostly Intended To Be Used On The Human Face, Head, And Neck. |
| 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 | OHS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5799 |
| Device | Light Based Over The Counter Wrinkle Reduction |
| Product Code | OHS |
| 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 | |
BIORENEW LABS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CENTRE LIGHT SOLUTIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CYNOSURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOME SKINOVATIONS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LA LUMIERE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LED INTELLECTUAL PROPERTIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LED TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
LED TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LG ELECTRONICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUTRA LUXE MD, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PS ADVANCED ENGINEERING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PULSADERM LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TROPHY SKIN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Quasar Bio-Tech, Inc. | II | Sep-05-2018 |