Diode Laser Therapy System
Sanhe LEFIS Electronics Co., Ltd. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Langfang
- Advisory committee description
- General, Plastic Surgery
- Address 1
- Bldg. 11 #1-101, Phase 1
- Address 2
- Zhongnan High Tech Yanjiao Science And Technology Innovation
- Statement or summary
- Summary
- Product code
- GEX
- Zip code
- 065201
- Applicant
- Sanhe LEFIS Electronics Co., Ltd.
- Decision date
- 2026-09-10
- Decision code
- SESE
- Country code
- CN
- Device name
- Diode Laser Therapy System
- Advisory committee
- SU
- Contact
- Dandan Wang
- K number
- K261562
- Date received
- 2026-05-11
- Review advisory committee
- SU
- Postal code
- 065201
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Powered Laser Surgical Instrument
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4810
- Device class
- 2
- Registration number
- 3009488834, 3009380063, 3005580113, 3013619029, 3011657089, 3037047060, 3038373471, 3042255006, 3005855240, 3006849754, 3004111573, 3009649442, 3016170453, 3004378299, 1318319, 3003340844, 3043011436, 1222993, 3012322232, 3004633032, 3034456223, 3004374705, 3037966040, 3005791808, 3019906161, 3020900954, 3009383334, 3038197172, 3046005941, 2939653, 3012133441, 3015807001, 3025268687, 1319211, 3007583504, 3021349626, 1037955, 3043012240, 3009887511, 1424785 +452 more
- FEI number
- 3009488834, 3009380063, 3005580113, 3013619029, 3011657089, 3037047060, 3038373471, 3042255006, 3005855240, 3006849754, 3004111573, 3009649442, 3016170453, 3004378299, 1318319, 3003340844, 3043011436, 3012322232, 3004633032, 3034456223, 3004374705, 3037966040, 3005791808, 3019906161, 3020900954, 3009383334, 3003067608, 3000219468, 3038197172, 3046005941, 2939653, 3002900199, 3012133441, 3015807001, 3025268687, 1319211, 3007583504, 3021349626, 1037955, 3043012240 +450 more