Definition: A LASER (Light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Sp
| Device Type ID | 5817 |
| Device Name | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Physical State | The Device Comes In A Wide Verity Of Shapes And Sizes. It Could Be Hand Held And With Weight Less Than One Pound Or It Could Be Heavy With Weight More Than Fifty Pounds. It Generally Has A Base Station With Attachments Such As Different Hand Piece(s) |
| Technical Method | A LASER (Light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beam(s) In Micro Range. The Classification Regulation 21 CFR 878.48 |
| Target Area | The Device Generally Targets Skin (including Dermis, Epidermis) And Underlying Soft Tissue Or Soft Tissue In General. |
| 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 | ONG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 5817 |
| Device | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Product Code | ONG |
| 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 | |
SRMC CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRIA BEAUTY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 42 |
Insufficient Information | 6 |
Device Issue | 1 |
Continuous Firing | 1 |
Unexpected Therapeutic Results | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Sparking | 1 |
| Total Device Problems | 53 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Solta Medical, Inc. | II | Apr-16-2014 |