Shenzhen Ulike Smart Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Shenzhen Ulike Smart Electronics Co., Ltd.” (first 2022, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Since 2017 the median was 60 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 58 |
| 2023 | 2 | 84 |
| 2024 | 8 | 82 |
| 2025 | 9 | 62 |
| 2026 | 3 | 29 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Ulike Smart Electronics Co., Ltd. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | 18 | 18 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 3 | 3 |
| GYB | Media, Electroconductive | 1 | 1 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
Review panels
- General and Plastic Surgery (21)
- Neurology (2)
Most recent Shenzhen Ulike Smart Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261325 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | OHT | 2026-05-21 | 29 |
| K260742 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | OHT | 2026-05-05 | 60 |
| K260511 | Ulike Reglow Light Therapy Device (UM10) | OHS | 2026-03-16 | 27 |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | OHT | 2025-10-01 | 28 |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) | OHS | 2025-10-01 | 110 |
| K251984 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | OHT | 2025-07-24 | 27 |
| 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) | OHT | 2025-07-11 | 105 |
| K250938 | Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN) | OHT | 2025-05-23 | 56 |
| K243749 | Jmoon Conductive Gel | GYB | 2025-04-08 | 124 |
| K250194 | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) | OHT | 2025-03-26 | 62 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Ulike Smart Electronics Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Ulike Smart Electronics Co., Ltd.?
FDA lists 23 510(k) clearances under the applicant name “Shenzhen Ulike Smart Electronics Co., Ltd.” (first 2022, latest 2026), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Ulike Smart Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Ulike Smart Electronics Co., Ltd. is 60 days. Since 2017: 60 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Ulike Smart Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are OHT (Light Based Over-The-Counter Hair Removal, 18); OHS (Light Based Over The Counter Wrinkle Reduction, 3); GYB (Media, Electroconductive, 1).
Next steps
- See all 23 Shenzhen Ulike Smart Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OHT, Shenzhen Ulike Smart Electronics Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.