Shenzhen Kaiyan Medical Equipment Co., Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Shenzhen Kaiyan Medical Equipment Co., Ltd.” (first 2023, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Since 2017 the median was 89 days, against 91 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 |
|---|---|---|
| 2023 | 2 | 86 |
| 2024 | 4 | 88 |
| 2025 | 11 | 90 |
| 2026 | 7 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Kaiyan Medical Equipment Co., Ltd. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | 15 | 15 |
| OAP | Laser, Comb, Hair | 5 | 5 |
| OLI | Fat Reducing Low Level Laser | 2 | 2 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
- General and Plastic Surgery (23)
- Neurology (1)
Most recent Shenzhen Kaiyan Medical Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109) | NFO | 2026-07-23 | 226 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | OHS | 2026-06-16 | 182 |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | OLI | 2026-05-04 | 62 |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | OLI | 2026-04-15 | 89 |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | OLP | 2026-03-04 | 90 |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | OHS | 2026-01-28 | 163 |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | OAP | 2026-01-23 | 63 |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | OAP | 2025-10-30 | 90 |
| K252272 | ORA Method LED Gua Sha (GS-04) | OHS | 2025-10-09 | 79 |
| K251781 | KALA MINI 2.0 (KALA-04) | OHS | 2025-09-04 | 85 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Kaiyan Medical Equipment 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. (160 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(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 RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Root Innovation Technology 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)
- Shenzhen Kentro Medical Electronics Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Kaiyan Medical Equipment Co., Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Shenzhen Kaiyan Medical Equipment Co., Ltd.” (first 2023, latest 2026), across 5 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 Kaiyan Medical Equipment Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Kaiyan Medical Equipment Co., Ltd. is 89 days. Since 2017: 89 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Kaiyan Medical Equipment Co., Ltd.?
The most frequent FDA product codes under this applicant name are OHS (Light Based Over The Counter Wrinkle Reduction, 15); OAP (Laser, Comb, Hair, 5); OLI (Fat Reducing Low Level Laser, 2).
Next steps
- See all 24 Shenzhen Kaiyan Medical Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OHS, Shenzhen Kaiyan Medical Equipment 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.