LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
FDA 510(k) clearance K253135 · decided 2025-12-23
Clearance details
- K-number
- K253135
- Device name
- LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
- Applicant
- Dongguan Yijiaming Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-25
- Decision date
- 2025-12-23
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dongguan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.