Definition: To Reduce Formation Of Bubbles During Laser Treatment Of Tattoos.
| Device Type ID | 5868 |
| Device Name | Transparent Patch For Use In Treatment Of Tattoos |
| Physical State | Liquid In A Transparent Double Sided Silicon Patch |
| Technical Method | Uses A Chemical Optical Clearing Agent To Interact With The Bubbles As They Are Attempting To Form To Prevent This Formation. |
| Target Area | Tattoos |
| 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 | PKO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5868 |
| Device | Transparent Patch For Use In Treatment Of Tattoos |
| Product Code | PKO |
| 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 | |
MERZ NORTH AMERICA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ON LIGHT SCIENCES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |