| Device |
powered light based non-laser surgical instrument |
| Regulation Description |
Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| 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 tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light. |
| 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) and touch tone/display screen or other mechanical buttons for user interactions |
| 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 Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | ONE |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4810
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
|
Third Party Review
|
Accredited Persons
|
