Definition: A Light Based Non-Laser Device Typically Indicated To Be Used For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ENT), Gynecology, Neurosurgery, Orthopedics (soft Tissu
| Device Type ID | 5815 |
| Device Name | Powered Light Based Non-laser Surgical Instrument |
| 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 | This Is A Powered Light Based But Non-laser Instrument That Uses Light Energy To Destroy Or Coagulate Tissue, Generally Soft Tissue. |
| 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 | ONE |
| 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 | 5815 |
| Device | Powered Light Based Non-laser Surgical Instrument |
| Product Code | ONE |
| 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 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |