Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Kaiyan Medical Equipment Co., Ltd. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
182 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-07-23 | 226 | 0 |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-06-16 | 182 | 0 |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY- | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-05-04 | 62 | 0 |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-04-15 | 89 | 0 |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-03-04 | 90 | 0 |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-28 | 163 | 0 |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWT | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-01-23 | 63 | 0 |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-30 | 90 | 0 |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-10-09 | 79 | 0 |
| K251781 | KALA MINI 2.0 (KALA-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-09-04 | 85 | 0 |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-08-14 | 134 | 0 |
| K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-07-11 | 120 | 0 |
| K250966 | CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-25 | 86 | 0 |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07 | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-17 | 76 | 0 |
| K250581 | KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-30 | 92 | 0 |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-05-22 | 87 | 0 |
| K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-03-03 | 243 | 0 |
| K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-02-14 | 168 | 0 |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-11-20 | 103 | 0 |
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-09-27 | 87 | 0 |
| K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-04-10 | 89 | 0 |
| K233556 | LED Eye mask (EY-20R, A20, EY-20N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024-01-04 | 59 | 0 |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-12-13 | 89 | 0 |
| K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2023-07-31 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda