Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011644607

FEI Number

3011644607

Entity Name

Shenzhen Kaiyan Medical Equipment Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, BaoAn District, Shenzhen Guangdong 518103, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shenzhen Kaiyan Medical Equipment Co., Ltd (Owner Number: 10049428)

Owner / Operator Contact Address

Building#3 and Building#5, 40th of Fuxin Street, Huaide Community, Fuyong Town ,, Bao'An District, Shenzhen, CN-GD 518103, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 HigherDOSE Red Light Mat 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 BON CHARGE RED LIGHT TOOTHBRUSH 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 MitoCLEAR 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-12-12
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-04-03
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-04-03
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2026-01-05
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2017-12-18
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-05-01
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2023-05-01
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2025-12-08
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2015-06-01
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2026-02-01
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-03-18
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-08-15
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2015-06-01
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-03-10
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-03-10
OLI	Fat Reducing Low Level Laser	General, Plastic Surgery	Class 2	878.5400	2025-03-10
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2015-06-01
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2021-07-26
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2021-07-26
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-07-26
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-05-26
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2015-06-01
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2025-01-03
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2025-08-22
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-08-22
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-08-22
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-08-22
OLI	Fat Reducing Low Level Laser	General, Plastic Surgery	Class 2	878.5400	2026-05-13
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-05-13
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2021-07-26
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-03-13
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2026-03-21
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-04-03
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-04-03
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-10-14
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-01-29
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2026-03-16
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2021-12-27
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-12-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-02-25
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-02-25
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-02-25
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2021-11-14
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2023-08-15
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-04-11
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2022-06-17
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-06-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-04-11
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2024-04-11
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-04-11
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2022-12-26
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2022-12-26
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2021-10-14
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2021-10-14
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-09-07
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-09-07
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-05-01
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-05-01
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-08-22
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	Class 2	878.4580	2015-06-01

Official Correspondent

Alain Dijkstra

US Agent Details

Kim Markwat Business: Light Tree Ventures USA LLC Email: kim@lighttreeventures.com Phone: (786) 6471640

Related Public Records

Same Entity

Shenzhen Kaiyan Medical Equipment Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Similar Registrations

Registration Number	Establishment Name	Location
3044622318	AMAZING IMPULSE, LLC	Lake Mary, FL, US
3043165181	Dongguan Yijiaming Technology Co., Ltd.	Dongguan Guangdong, CN
3042970900	XPLR LTD.	Yehud Tel Aviv, IL
3015619973	JOICOM CORPORATION	Eastvale, CA, US
3012541016	OPATRA LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011644607. Last updated year: 2026. Please use registration number 3011644607 when referencing this establishment in official correspondence.