Shenzhen Kaiyan Medical Equipment Co., Ltd
Shenzhen Guangdong, CN
Shenzhen Kaiyan Medical Equipment Co., Ltd appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Shenzhen Kaiyan Medical Equipment Co., Ltd between 2023 and 2026. The busiest year on record is 2025, with 11. The most recent is 2026, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 11 |
| 2026 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109) | NFO | Substantially Equivalent | |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | OHS | Substantially Equivalent | |
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | OLI | Substantially Equivalent | |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | OLI | Substantially Equivalent | |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | OLP | Substantially Equivalent | |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | OHS | Substantially Equivalent | |
| K253669 | TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) | OAP | Substantially Equivalent | |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) | OAP | Substantially Equivalent | |
| K252272 | ORA Method LED Gua Sha (GS-04) | OHS | Substantially Equivalent | |
| K251781 | KALA MINI 2.0 (KALA-04) | OHS | Substantially Equivalent | |
| K251012 | TRUDERMAL Pro (ZLD-390) | OHS | Substantially Equivalent | |
| K250761 | KALA Therapy Wand (Model: KALA-03) | OHS | Substantially Equivalent | |
| K250966 | CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) | OHS | Substantially Equivalent | |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | OAP | Substantially Equivalent | |
| K250581 | KALA Red Light Face Mask (KALA-01) | OHS | Substantially Equivalent | |
| K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043) | OHS | Substantially Equivalent | |
| K241947 | EnergyLounger (TY-01) | OHS | Substantially Equivalent | |
| K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | OHS | Substantially Equivalent | |
| K242363 | HIGHERDOSE Red Light Hat (HG-120K) | OAP | Substantially Equivalent | |
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | OHS | Substantially Equivalent | |
| K240089 | Face Patches (MT-12MA, MT-12MC) | OHS | Substantially Equivalent | |
| K233556 | LED Eye mask (EY-20R, A20, EY-20N) | OHS | Substantially Equivalent | |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | OHS | Substantially Equivalent | |
| K231321 | Nooance Led And Laser Helmet | OAP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011644607 | 3011644607 | Shenzhen Kaiyan Medical Equipment Co., Ltd | Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Shenzhen Guangdong 518103 CN | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OLIFat Reducing Low Level Laser
- NXRFixation, Vision Training, Binocular
- EEGHeat Source For Bleaching Teeth
- HGZHeater, Perineal, Direct Contact
- ILYLamp, Infrared, Therapeutic Heating
- OAPLaser, Comb, Hair
- OHSLight Based Over The Counter Wrinkle Reduction
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-1
- KYTLight, Examination, Medical, Battery Powered
- FSZLight, Surgical, Carrier
- FSYLight, Surgical, Ceiling Mounted
- FSSLight, Surgical, Floor Standing
- ISAMassager, Therapeutic, Electric
- OLPOver-The-Counter Powered Light Based Laser For Acne
- GEXPowered Laser Surgical Instrument
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
- JEQToothbrush, Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain