Diode Laser Therapy System
FDA 510(k) clearance K192569 · decided 2019-12-13
Clearance details
- K-number
- K192569
- Device name
- Diode Laser Therapy System
- Applicant
- San HE Lefis Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-18
- Decision date
- 2019-12-13
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Yanjiao Development Zone, Sanhe County,, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.