Product areas
FDA product code distribution
Shenzhen Fansizhe Science and Technology Co., Ltd.
Country / region:China (CN)
510(k) submissions
5
Filtered: OHT
Latest clearance
2025-12-29
Product codes
1
OHT
510(k) submissions
5 total · filtered by OHT
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | OHT | Class 2 | 2025-12-29 |
| K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | OHT | Class 2 | 2025-07-14 |
| K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K | OHT | Class 2 | 2023-03-28 |
| K221569 | Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K | OHT | Class 2 | 2022-06-30 |
| K212881 | Intense Pulsed Light (IPL) System | OHT | Class 2 | 2022-04-11 |
Company profile
- Canonical name
- Shenzhen Fansizhe Science and Technology Co., Ltd.
- Country
- China(CN)
- Address
- 2nd, 3rd And 4th Floors, #11, Henggangxia Industrial Zone Xiangshan Community, Xinqiao St., Bao’An District Shenzhen, CN 518125
Cited predicates
8- K241998
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
- K251173
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
- K221569
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
- K230739
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
- K241998
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
- K220222
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
- K183217
IPL Hair Removal Device
- K212881
Intense Pulsed Light (IPL) System
Shenzhen Fansizhe Science and Technology Co., Ltd. references 8 predicate/reference devices
Cited as predicate
10- K253881
Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
- K252234
IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
- K251176
IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
- K251173
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
- K250131
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
- K241120
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
- K232575
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
- K231613
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
- K231215
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
- K221569
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
10 submissions cite Shenzhen Fansizhe Science and Technology Co., Ltd. as a predicate