510(k) K240649
- Device
- Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
- Applicant
- Shenzhen Ulike Smart Electronics Co., Ltd.
- 510(k) number
- K240649
- Product code
- OHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-21
- Date received
- 2024-03-07
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Blue Yang
- Address
- 810, Bldg. 1, Xunmei Science And Technology Plz., # 8 Keyuan Rd., Science Park Community, Yuehai Sub-Distri Shenzhen CN 518000 518000
FDA Registration Numbers#
- 3018366453
- 3023808190
- 3013494333
- 3015542362
- 3031182672
- 3023272681
- 3010359222
- 3043105515
- 3042254846
- 3023876598
- 3017905264
- 3026132991
- 1222304
- 3010027944
- 3010912900
- 3017954802
- 3033890479
- 3015192276
- 3029992391
- 3019577501
- 3043657394
- 3016750352
- 3023339107
- 3012104022
- 3019015047
- 3017555752
- 3036720861
- 3026360847
- 3017813743
- 3023339103
- 3030234143
- 3021329660
- 3038373471
- 3015452693
- 3011307265
- 3027645761
- 3027651556
- 3014527840
- 3010360273
- 3011792045
- 3048248141
- 3021599225
- 3016076077
- 3017400436
- 3004635398
- 3010677917
- 3038319732
- 3027605738
- 3014327421
- 3011547157
- 3012133441
- 3023281259
- 3015924074
- 3011070163
- 3043749884
- 3007238544
- 3027847716
- 3008925277
- 3007744197
- 3037341611
- 3014386328
- 3033795858
- 3037874486
- 3033793026
- 3015619973
- 3011964664
- 3031233197
- 3039435282
- 3029944286
- 3030234086
- 3004069780
- 3044572954
- 3017132875
- 3033840300
- 3012776156
- 3014737458
- 3021338880
- 3017619615
- 3007543044
- 3033879491
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OHT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261977 | Braun Aura 9 (6042) | Cyden Limited | 2026-09-25 |
| K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | ONE BEAUTY Technology Co., Ltd. | 2026-09-18 |
| 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 |