FDA Registration
Active
🇨🇳 China
Shenzhen Kaiyan Medical Equipment Co., Ltd
Reg #: 3011644607
·
FEI: 3011644607
·
Expires 2026
Products
17
Proprietary Names
242
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Registration Number
- 3011644607
- FEI Number
- 3011644607
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, BaoAn District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221444
Owner / Operator
- Firm Name
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Operator Number
- 10049428
- Address
- Building#3 and Building#5, 40th of Fuxin Street, Huaide Community, Fuyong Town ,, Bao'An District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518103
- Country
- CN
- Correspondent
- Alain Dijkstra
US Agent
- Business Name
- Light Tree Ventures USA LLC
- Contact Name
- Kim Markwat
- Address
- 6240 NE 4TH CT
- City
- Miami
- State
- FL
- ZIP
- 33138
- Country
- US
- [email protected]
- Phone
- 786 6471640
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2022-12-12 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-04-03 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2023-05-01 |
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2023-05-01 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2015-06-01 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2015-06-01 |
| Fat Reducing Low Level Laser | OLI | Class 2 | General, Plastic Surgery | No | 2025-03-10 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2015-06-01 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-08-22 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2026-03-16 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-02-25 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2021-11-14 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2015-06-01 |
| Heater, Perineal, Direct Contact | HGZ | Class 2 | Obstetrics/Gynecology | No | 2024-11-19 |
| Fixation, Vision Training, Binocular | NXR | Class 1 | Ophthalmic | No | 2025-02-18 |
| Light Based Treatment For Cold Sores Herpes Simplex Virus-1 | OKJ | Class 2 | General, Plastic Surgery | No | 2022-10-23 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2023-12-25 |
Proprietary Names
CurrentBody Skin LED Eye Mask
CurrentBody Skin LED Eye Perfector
LED Lip Perfector
ORA Method LED Gua Sha (GS-04)
LumiNeus Nasal Accessory
Kala Restore Wrap
Lumi Boosted Red and Infrared Body Pad
Fringe Red Light Therapy Mat
Fringe Red Light Therapy Wrap(ZLD-120A)
Infraredi Body Wrap Plus
CurrentBody Skin LED Hand Perfector
Fringe Light Therapy Tiny Wrap (Model: ZLD-60BX)
CurrentBody Skin LED Hand Mask
Rojo Boost (XG-02)
NEUROWRAP
Aduro LED Neck Mask
HigherDOSE Redlight Neck Enhancer
LuminousRLT light pad system
KINEON MOVE+
Neck & Decolletage LED
Multifunction LED mask
LASERKURE
Light Therapy Yoga Mat (ZLD-207)
Arunalight Eyewear Device
Aduro Neck Mask
KALA RED LIGHT NECK REJUVENATOR
CF X-Back Belt with RLT Pad
UltraBEAM KNEE THERAPY DEVICE
UltraBEAM SHOULDER THERAPY DEVICE
Solawave Neck + Chest Rejuvenating Mask
CurrentBody SkinLED Neck & Decolletage Mask
Lumi Bio-Connect Helmet Pad
Revitalizing LED Yoga Mat
MINI 2
Fringe red light therapy wraps
Infrared LED Mat
Kineon MOVE+Pro
UltraBEAM HAND THERAPY DEVICE
Lumaflex Panel
HIGHERDOSE BODY SCULPTOR
LED Esthetics Silicone Neck
CurrentBody Skin LED Neck & Decolletage Mask: Sonia Edition (2025)
Sonia Selaire x CurrentBody S2 Neck & Dec Mask
iRESTORE Flex LED Belt
Fringe Red Light Therapy Extra Long Wrap (ZLD-150P)
Lipo Mat
CeraThrive - TD-02
Silicone Head pad
Hammacher Schlemmer Vibration and LED Therapy Wrap (Model #98350 and #55550)
HigherDOSE Red Light Mat
LACEVO EMPOWER RED AND NEAR INFRARED LIGHT THERAPY BREAST CARE SET (Model: E1)
Fringe Red Light Therapy Head Wrap (ZLD-150R)
Deceptor Wand
Fringe Red Light Therapy Shoulder & Back Wrap (HJB-120)
fringe light therapy neck & chest mask
UltraBEAM NECK THERAPY DEVICE
LIGHT THERAPY BODY RECOVERY PATCH (ZLD-05E)
GLAMCOR LED THERAPY PANEL
Fringe Red Light Therapy Multi-joint Wrap (HX-90)
BON CHARGE RED LIGHT TOOTHBRUSH REFILL
JTAV Glow-Pro Neck & Decollete Mask (ZLD-50AX)
Fringe Red Light Therapy Panel
Lumi Enhanced Super T Neuro Pad
UltraBEAM LOW BACK THERAPY DEVICE
Fringe Red Light Therapy Clinical Pad (Model: EA-37C Pro)
caring mill Portable Red Light Therapy Device
TRUDERMAL Glow Neck & Decolletage
CRAMER FRINGE RED LIGHT THERAPY WRAP
Fringe Red Light Therapy Clinical Pad (EA-37C Pro)
CurrentBody Skin LED Light Therapy Panel
BON CHARGE RED LIGHT TOOTHBRUSH
Red Light Therapy Wrap
Lumi Boosted Red and Infrared Pain Buster
Neuronic Light
Infraredi Pro(Model: Pro Mini, Pro Max, Pro Max Plus)
KALA THERAPY HAT
EXO HAIR Red Light LED Hair Brush
X-FORTIFY Red Light LED Hair Brush
Q-Renew LLLT Hair Growth Helmet
TRUDERMAL Halo(Model: M-180A)
LED Esthetics Hair Pro (Model:HG-180A)
SKILLYES Hair Growth Helmet (Model:TK-300)
CurrentBody Skin LED Mask
LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
SHENZHEN KAIYAN MEDICAL CO LTD
EnergyLounger
KALA THERAPY WAND
RIKI LOVES RIKI RIKI Miracle acne patch
CurrentBody Skin Anti-Acne LED Pen
CurrentBody Skin Anti-Blemish LED Pen
Aduro Plam
Solawave Bye Acne 3 Minute Light Therapy
Solawave Bye Acne
LED Esthetics Acne Pen
Groomie Hers GlowUp Acne Wand
caring mill Anti-Acne Light Therapy Device
Solawave 2-in-1 Skincare Mini
UNICLED HELMET OMEGA 5
RIKI LOVES RIKI HAIR GROWTH CAP
HIGHERDOSE RED LIGHT HAT
SKILLYES HAIR GROWTH CAP
LED Esthetics Hair Pro
Infraredi Hair Growth Hat
SKILLYES HAIR GROWTH HELMET
SKIN GYM Pro Red Light LED Cap
CurrentBody Skin Dual Light Hair Growth Helmet
CurrentBody Skin Dual Light Hair Growth Headband
CurrentBody Skin Dual Light Hair Growth Helmet (Medium)
CurrentBody Skin Dual Light Hair Growth Helmet (Large)
KALA Therapy Wand(KALA-03)
iRESTORE Sculpt LED Belt
Radiant Renewal Skincare Wand
LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
ELLE Radiance Boost Pro Facewear
LUSTRE ClearSkin Renew Pro Facewear Mask
FACEGYM LIGHTWEAR LED FACE MASK
HIGHERDOSE Red and Infrared Light Mask
Lumin Eye Mask
Led Eye Mask
Amifiy LED EYE MASK(EY-40M)
LOOKEE® ReviveGlow Pro LED Eye Rejuvenator(Model: A20)
Amifiy LED EYE MASK(EY-40N)
Amifiy LED EYE MASK(EY-20RB)
Dogface Red Light Eye Mask
Solawave Eye Recovery Pro
Hammacher Schlemmer The LED Therapy Eye Mask
AMIRO LED LIGHT EYE MASK (Model: ABYM02)
CBG DEVICES LED EYE MASK (EY-20R)
Lumi Boosted Restoration Eye Mask
Oren LED Perioral Light Therapy System
Cleolips
RajaniMD Plasma GLO LED LIP MOUTH (YT-14)
Lush Lip Patch (CT-38)
CurrentBody Skin LED ANTI-ACNE MASK
CURRENTBODY Skin 4-IN-1 LED FACE MASK
CURRENTBODY SKIN LED MULTI-LIGHT THERAPY MASK
CurrentBody Skin LED ANTI-ACNE MASK SERIES 2
Heat source for bleaching teeth
Nooance Led And Laser Helmet X400 (Model: M-282B)
Nooance Led And Laser Helmet X400 (Model: M-282A)
NOOANCE LED AND LASER HELMET(Model: M-120, M-282 PRO)
Nooance Led And Laser Helmet Expert X600 (Model: M-600B)
Nooance Led And Laser Helmet Expert X600 (Model:M-600)
Smart Triad 3LT
Smart Triad 3LT hand
Triad 3LT-Knee
Smart Triad 3LT foot & ankle
Smart Triad 3LT wrist
Smart Triad 3LT shoulder
Skin Care Beauty Mask
LED Esthetics Lite Mask V2
LED Esthetics Glotech Minis
Rajani MD PlasmaGLO Duo(MT-06A)
Trudermal Nano Eye Corrector
UNICLED NECK & CHIN MASK 5 (MT-28B)
SKIN GYM LED Eye Patch (MT-12S)
SKIN PARADE-LED BAND-AID
Magic Moon Patch (MT-17)
RIKI HIGH ROLLER
TRUDERMAL Nano Eye Corrector
Fix and Snatch!
SuperStar Patch
MitoCLEAR
Mini LED Patch
TRUDERMAL Nano Blemish Corrector
Clarifying Led Patch
Rajani MD PlasmaGLO GUA SHA (GS-06)
Metamorphosis MorphoGlow
Metamorphosis RubyRadiance
LED EYE PATCHES (MT-12S)
Trudermal Nano Blemish Corrector
RajaniMD Facial Mask (MK-78B)
NOOANCE LED MASK MULTI-FUNCTIONS (ZLD-50P)
Lumi Renew Facial Rejuvenator
NOOANCE LED FACIAL MASK PRO (MK-99M)
Trudermal Glow Neck Decolletage & Hand
NOOANCE LED FACIAL MASK Essential (MK-99)
MitoGLOW Mask (Model: MJ-252)
NOOANCE BEAUTY LED MASK ACCESS+ (MJ-66D,MJ-66DA)
Therapy Device for Skin Care
Ember Wellness Rejuvenating Light Therapy Mask
JTAV GLOW-PRO LED MASK
Aduro Blue Facial Mask
LED Esthetics Silicone Mask
Skinletics Light Therapy Face Mask (MK-02N)
SKILLYES LED LIGHT THERAPY Facial Mask(MK-03BI, MK-03BM, MK-03BK)
Lumi Clear Complexion Mask
UNICLED 5 CENTURION KOREAN MASK
Light Therapy PRO Face Mask (MJ-78A)
Infraredi LED Light Therapy Mask
Cleo mask
LED facial mask
NOOANCE LED FACIAL MASK ELITE X600 (MJ-66C)
NOOANCE LED FACIAL MASK PRO (MK-99A)
LED ESTHETICS MASK PRO PLUS
MAYSAMA AURA LED LIGHT THERAPY NECK2DEC
NOOANCE LED FACIAL MASK PRO (MK-99MA)
NOOANCE LED FACIAL MASK AURION X252(MJ-66DB)
NOOANCE LED FACE AND BODY DEVICE FLEXIDOME PRO (ZLD-360K)
Trudermal Glow
Fringe light therapy face mask
HORIZON ECLIPSE Pro Kit (MK-600)
MAYSAMA AURA LED LIGHT THERAPY FACE MASK
Solawave Wrinkle Retreat Light Therapy Face Mask
MAYSAMA LED LIGHT THERAPY HAND GLOVE(ST-72A)
Skin Gym Pro LED Light Therapy Mask
Rajani MD PlasmaGLO LED Face Neck Hair Mask (MK-92)
Boost The Light Salon® Advanced LED Mask Face
KALA Red Light Face Mask
Q-Rejuvalight Pro Facewear
CurrentBody Skin LED Light Therapy Mask Series 2
Light, surgical, carrier
CurrentBody Hair Helmet (Large)
CurrentBody Skin LED Hair Regrowth
CurrentBody Hair Helmet (Medium)
Fringe Light Therapy Wand
LUSTRE ClearSkin REVIVE Mask
Hammacher Schlemmer Anti-Aging LED Facial Rejuvenating Mask (Model #98670)
Mask & Glo Pro LED Mask
Aduro Facial Mask
Angel Kiss Light Beauty Mask
Peachaboo Silicone LED Light Therapy Mask
Bestqool LED Mask
Lifepro LED mask(Mode:LP-VZCR-BLK)
Luxeclinical Equinox LED Mask
Angela Caglia Crystal LED Face Mask
Lumi Boosted Relaxation Eye Mask
RIKI loves RIKI baby face mask
Lola Facial Mask
Clarifying Led Mask
Equinox LED Mask
Skillyes LED LIGHT THERAPY Facial Mask
REALONE FACIAL MASK
Total Vision Training and Restoration System
LED Esthetics Herpes Pen
Walgreen Cold Sore Device (QPZ-01)
Infrared Light Therapy Cold Sore Treatment Device
Groomie Hers ClearLip Cold Sore Wand
CurrentBody Skin LED LIGHT THERAPY MASK
Sonia Selaire x CurrentBody S2 Mask
CurrentBody Skin LED Light Therapy Mask: Sonia Edition (2025)
Solawave 4-in-1 Skincare Wand
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device