510(k) K213020
- Device
- IPL Hair Removal Machine
- Applicant
- Shenzhen Borria Technology Co.,Ltd
- 510(k) number
- K213020
- Product code
- OHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-12-16
- Date received
- 2021-09-20
- Regulation
- 878.4810
- Classification name
- Light Based Over-the-counter Hair Removal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Li Zhenqiang
- Address
- 22a, Tianmian City Bldg., #4026 Shennan Middle Rd., Tianmian Community, Huafu St., Futian District Shenzhen CN 518000 518000
FDA Registration Numbers#
- 3033793026
- 3010359222
- 3027645761
- 3006580954
- 3008925277
- 3023339103
- 3010677917
- 3014787341
- 3007238544
- 3023339107
- 3033840300
- 3011792045
- 3019577501
- 3026360847
- 3015542362
- 3017619615
- 3043749884
- 3011964664
- 3014527840
- 3031182672
- 3015619973
- 3010360273
- 3023876598
- 3014327421
- 3026132991
- 3037341611
- 3015452693
- 3012776156
- 3016750352
- 3038373471
- 3038319732
- 3019015047
- 3027847716
- 3017954802
- 3030234086
- 3030233762
- 3013494333
- 3013446079
- 3011547157
- 3027344219
- 3015924074
- 3014737458
- 3018366453
- 3004069780
- 3043177840
- 3016994791
- 3007744197
- 3010027944
- 3011070163
- 3027605738
- 3043657394
- 3043745121
- 3022594978
- 3017905264
- 3037874486
- 3042254846
- 3033879491
- 3017400436
- 3030234143
- 3007543044
- 3010912900
- 3021338880
- 3043105515
- 3011307265
- 3044572954
- 3023281259
- 3029944286
- 1222304
- 3015989868
- 3012133441
- 3012104022
- 3027651556
- 3017813743
- 3017555752
- 3016076077
- 3023272681
- 3017132875
- 3031233197
- 3029792043
Source Documents#
Other 510(k) Records For Product Code OHT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261705 | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 2026-08-10 |
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-05-21 |
| K260594 | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) | Shenzhen Xiazhifeng Electronic Co., Ltd. | 2026-05-20 |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2026-05-05 |
| K260518 | IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2026-04-21 |
| K254047 | Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2026-03-11 |
| K253666 | IPL Hair Removal Device (Models: T31A, T32A) | Shenzhen Mlay Intelligent Technology Co., Ltd. | 2026-02-23 |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2025-12-29 |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. | 2025-12-23 |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) | Dongguan Lide Electric Appliance Co., Ltd. | 2025-11-25 |
| K253035 | IPL Hair Removal Device (SYL001AZ, SYL002AZ) | Gu'An Yeolight Smart Electronics Co., Ltd. | 2025-11-19 |
| K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) | Alovea Healthcare Co. , Ltd. | 2025-11-14 |
| 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) | Shenzhen Qiaochengli Technology Co., Ltd. | 2025-10-14 |
| K252209 | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) | Foshan Jindi Electric Appliance Co., Ltd. | 2025-10-10 |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. | 2025-10-02 |
Legacy Summary#
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FDA Review#
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