Chrysalis Intelligence · Sponsors · Shenzhen Kaiyan Medical Equipment Co., Ltd.

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Shenzhen, CN · 24 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
24
2023-07-31 → 2026-07-23
Last 12 months
10
Product codes
5
Most recent
2026-07-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OHS Light Based Over The Counter Wrinkle Reduction Class II General, Plastic Surgery 15 2026-06-16
OAP — — — 5 2026-01-23
OLI Fat Reducing Low Level Laser Class II General, Plastic Surgery 2 2026-05-04
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes Class II Neurology 1 2026-07-23
OLP Over-The-Counter Powered Light Based Laser For Acne Class II General, Plastic Surgery 1 2026-03-04
Filings

All 510(k) clearances (24)

Date K-number Device Code Class Specialty
2026-07-23 K253932 FACEGYM Pro Device (HD-109) NFO Class II Neurology
2026-06-16 K254025 LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) OHS Class II General, Plastic Surgery
2026-05-04 K260688 Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) OLI Class II General, Plastic Surgery
2026-04-15 K260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) OLI Class II General, Plastic Surgery
2026-03-04 K253878 LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) OLP Class II General, Plastic Surgery
2026-01-28 K252603 HIGHERDOSE Body Sculptor (Model: GS-03) OHS Class II General, Plastic Surgery
2026-01-23 K253669 TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) OAP — —
2025-10-30 K252414 Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) OAP — —
2025-10-09 K252272 ORA Method LED Gua Sha (GS-04) OHS Class II General, Plastic Surgery
2025-09-04 K251781 KALA MINI 2.0 (KALA-04) OHS Class II General, Plastic Surgery
2025-08-14 K251012 TRUDERMAL Pro (ZLD-390) OHS Class II General, Plastic Surgery
2025-07-11 K250761 KALA Therapy Wand (Model: KALA-03) OHS Class II General, Plastic Surgery
2025-06-25 K250966 CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) OHS Class II General, Plastic Surgery
2025-06-17 K251017 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) OAP — —
2025-05-30 K250581 KALA Red Light Face Mask (KALA-01) OHS Class II General, Plastic Surgery
2025-05-22 K250532 Solawave 2-in-1 Skincare Mini (Model: 61043) OHS Class II General, Plastic Surgery
2025-03-03 K241947 EnergyLounger (TY-01) OHS Class II General, Plastic Surgery
2025-02-14 K242593 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) OHS Class II General, Plastic Surgery
2024-11-20 K242363 HIGHERDOSE Red Light Hat (HG-120K) OAP — —
2024-09-27 K241933 HIGHERDOSE Red and Infrared Light Mask (MK66-L) OHS Class II General, Plastic Surgery
2024-04-10 K240089 Face Patches (MT-12MA, MT-12MC) OHS Class II General, Plastic Surgery
2024-01-04 K233556 LED Eye mask (EY-20R, A20, EY-20N) OHS Class II General, Plastic Surgery
2023-12-13 K232863 Radiant Renewal Skincare Wand (HD-15, HD-15A) OHS Class II General, Plastic Surgery
2023-07-31 K231321 Nooance Led And Laser Helmet OAP — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence