TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
FDA 510(k) clearance K251464 · decided 2025-10-03
Clearance details
- K-number
- K251464
- Device name
- TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
- Applicant
- Jeisys Medical Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2025-05-13
- Decision date
- 2025-10-03
- Days to decision
- 143 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
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.