Shenzhen Ionka Medical Technology Co., Ltd.

Country / region:China (CN)

510(k) submissions

Latest clearance

2023-05-26

Product codes

OHT

Cited as predicate

View list →

Product areas

FDA product code distribution

OHT1

510(k) submissions

1 total

K number	Device name	Product code	Class	Decision date
K230739	Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200	OHT	Class 2	2023-05-26

Company profile

Canonical name: Shenzhen Ionka Medical Technology Co., Ltd.
Country: China(CN)
Address: Rm. 601, # 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang St., Guang Shenzhen, CN 518132

Cited predicates

K221214
—
—
Not ingested
K222432
IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439
Hunan Guangye Biotechnology Co., Ltd.

Shenzhen Ionka Medical Technology Co., Ltd. references 2 predicate/reference devices

Cited as predicate

K251173
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
Shenzhen Fansizhe Science and Technology Co., Ltd.
K251000
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
Shenzhen Chuangtong Yigou Technology Co., Ltd.
K250942
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
Shenzhen Ulike Smart Electronics Co., Ltd.
K243085
IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
Zhuzhou Goldenhot Medical Technology Co., Ltd.
K243036
IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)
Bestway Plastic and Metal Products , Ltd.
Not ingested
K242039
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
Shenzhen Ulike Smart Electronics Co., Ltd.
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)
Shenzhen Ulike Smart Electronics Co., Ltd.
K241343
IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140)
Shenzhen Lescolton Electrical Appliance Co., Ltd.
K240583
IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
K232499
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
Shenzhen Lescolton Electrical Appliance Co., Ltd.

10 submissions cite Shenzhen Ionka Medical Technology Co., Ltd. as a predicate