Shenzhen Kaiyan Medical Equipment Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 17 device types, 21 products catalogued, 24 clearances.
Shenzhen Kaiyan Medical Equipment Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Laser, Comb, Hair, Toothbrush, Powered and 15 other device types. 21 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
17device types registered with the FDA
21products catalogued under its own name
24510(k) clearances
Registration
| Registered name | Shenzhen Kaiyan Medical Equipment Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011644607 |
| FEI number | 3011644607 |
| DUNS | 543062382 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市开颜医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440300687562172B |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town |
| Postal code | 518103 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Fat Reducing Low Level Laser | Class 2 | iRESTORE Sculpt LED Belt, EnergyLounger, HigherDOSE Red Light Mat, Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro) | 2025 | 6 |
| Fixation, Vision Training, Binocular | Class 1 | Total Vision Training and Restoration System | 2025 | 3 |
| Heat Source For Bleaching Teeth | Class 1 | Teeth Whitening Device (Model: YT-11E), Heat source for bleaching teeth | 2021 | 56 |
| Heater, Perineal, Direct Contact | Class 2 | Fringe Light Therapy Wand | 2024 | 1 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | caring mill Anti-Acne Light Therapy Device, Solawave Bye Acne 3 Minute Light Therapy, CurrentBody Skin Anti-Acne LED Pen, LED Esthetics Acne Pen, Aduro Plam, RIKI LOVES RIKI RIKI Miracle acne patch and 90 more | 2015 | 235 |
| Laser, Comb, Hair | Class 2 | CurrentBody Skin Dual Light Hair Growth Helmet, CurrentBody Skin Dual Light Hair Growth Headband, CurrentBody Skin Dual Light Hair Growth Helmet (Large), CurrentBody Skin Dual Light Hair Growth Helmet (Medium), Nooance Led And Laser Helmet X400 (Model: M-282A), Nooance Led And Laser Helmet X400 (Model: M-282B) and 23 more | 2023 | 30 |
| Light Based Over The Counter Wrinkle Reduction | Class 2 | LED Neck Beauty Mask, Project E Beauty Lumalux Face V2 3D LED Red Light Therapy Mask (PE762), Project E Beauty Lumalux Face+ V2 3D LED Red Light Therapy Face & Neck Mask(PE763), Trudermal Glow Neck Decolletage & Hand, Fringe Light Therapy Neck & Chest Mask (ZLD-50AK), Mini LED Patch and 134 more | 2021 | 67 |
| Light Based Treatment For Cold Sores Herpes Simplex Virus-1 | Class 2 | Walgreen Cold Sore Device (QPZ-01), Infrared Light Therapy Cold Sore Treatment Device, Groomie Hers ClearLip™ Cold Sore Wand, LED Esthetics Herpes Pen | 2022 | 1 |
| Light, Examination, Medical, Battery Powered | Class 1 | Shenzhen Kaiyan Medical Co Ltd | 2015 | 53 |
| Light, Surgical, Carrier | Class 2 | Light, surgical, carrier | 2015 | 2 |
| Light, Surgical, Ceiling Mounted | Class 2 | 2015 | 5 | |
| Light, Surgical, Floor Standing | Class 2 | 2015 | 1 | |
| Massager, Therapeutic, Electric | Class 1 | Radiant Renewal Skincare Wand, KALA Therapy Wand(KALA-03) | 2023 | 437 |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | LED Neck Beauty Mask, Project E Beauty Lumalux Face V2 3D LED Red Light Therapy Mask (PE762), Project E Beauty Lumalux Face+ V2 3D LED Red Light Therapy Face & Neck Mask(PE763), Trudermal Glow Neck Decolletage & Hand, Fringe Light Therapy Neck & Chest Mask (ZLD-50AK), Mini LED Patch and 94 more | 2021 | 59 |
| Powered Laser Surgical Instrument | Class 2 | Mini LED Patch, LED Esthetics Glotech Minis, Rajani MD PlasmaGLO Duo(MT-06A), Metamorphosis MorphoGlow, SuperStar Patch, Riki High Roller and 17 more | 2024 | 92 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class 2 | Solawave 4-in-1 Skincare Wand, FACEGYM Pro Device (HD-109) | 2023 | 22 |
| Toothbrush, Powered | Class 1 | BON Charge RED Light Toothbrush | 2026 | 191 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| CurrentBody Skin™ | OAP | 6 |
| CurrentBody Skin™ | OHS | 4 |
| Solawave | OHS | 3 |
| Dr.naomi | OHS | 2 |
| Tommie copper | ILY | 2 |
| Higherdose | OHS | 2 |
| Lustre | OLP | 2 |
| Nooance | OAP | 2 |
| Lumaflex | ILY | 2 |
| Lustre | OHS | 1 |
| EnergyLounger | OHS | 1 |
| Trudermal | OHS | 1 |
| Solawave | NFO | 1 |
| Higherdose | ILY | 1 |
| Higherdose | OAP | 1 |
| Kineon | ILY | 1 |
| Lookee | OHS | 1 |
| Exoceuticals | OAP | 1 |
| Cosmotology | OHS | 1 |
| CurrentBody™ | OHS | 1 |
| Ellodi | OHS | 1 |
Clearances
24 clearances name Shenzhen Kaiyan Medical Equipment Co., Ltd. as applicant. 11 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253932 | 2026-07-23 | NFO | Traditional | This company |
| K254025 | 2026-06-16 | OHS | Traditional | This company |
| K260688 | 2026-05-04 | OLI | Traditional | This company |
| K260129 | 2026-04-15 | OLI | Traditional | This company |
| K253878 | 2026-03-04 | OLP | Traditional | This company |
| K252603 | 2026-01-28 | OHS | Traditional | This company |
| K253669 | 2026-01-23 | OAP | Traditional | This company |
| K252414 | 2025-10-30 | OAP | Traditional | This company |
| K252272 | 2025-10-09 | OHS | Traditional | This company |
| K251781 | 2025-09-04 | OHS | Traditional | This company |
| K251012 | 2025-08-14 | OHS | Traditional | This company |
| K250761 | 2025-07-11 | OHS | Traditional | This company |
| K250966 | 2025-06-25 | OHS | Traditional | This company |
| K251017 | 2025-06-17 | OAP | Traditional | This company |
| K250581 | 2025-05-30 | OHS | Traditional | This company |
| K250532 | 2025-05-22 | OHS | Traditional | This company |
| K241947 | 2025-03-03 | OHS | Traditional | This company |
| K242593 | 2025-02-14 | OHS | Traditional | This company |
| K242363 | 2024-11-20 | OAP | Traditional | This company |
| K241933 | 2024-09-27 | OHS | Traditional | This company |
| K240089 | 2024-04-10 | OHS | Traditional | This company |
| K233556 | 2024-01-04 | OHS | Traditional | This company |
| K232863 | 2023-12-13 | OHS | Traditional | This company |
| K231321 | 2023-07-31 | OAP | Traditional | This company |
| K230720 | 2023-07-03 | OLP | Traditional | Light Tree Ventures Europe B.V. |
| K223893 | 2023-05-16 | OHS | Traditional | Light Tree Ventures Europe B.V. |
| K230042 | 2023-04-28 | OHS | Traditional | Light Tree Ventures Europe B.V. |
| K230597 | 2023-04-28 | OAP | Traditional | Light Tree Ventures Europe B.V. |
| K221775 | 2022-12-20 | OHS | Traditional | Light Tree Ventures Europe B.V. |
| K221444 | 2022-12-08 | OHS | Traditional | Light Tree Ventures Europe B.V. |
| K222205 | 2022-10-07 | OKJ | Traditional | Light Tree Ventures Europe B.V. |
| K220168 | 2022-05-17 | OHS | Traditional | Shenzhen Kaiyan Medical Co., Ltd. |
| K213024 | 2021-12-22 | OHS | Traditional | Shenzhen Kaiyan Medical Co., Ltd. |
| K203271 | 2021-07-21 | OLP | Traditional | Shenzhen Kaiyan Medical Co., Ltd. |
| K202390 | 2021-07-14 | OHS | Traditional | Shenzhen Kaiyan Medical Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Employees | 1600+ |
| Factory area | 60,000 sq m |
| Main products | LED face masks, Red light therapy panels, Red light therapy beds, Wearable LED wraps |
| Certifications | FDA, CE, ISO 13485, MDSAP, BSCI, FCC, TGA, PSE |
| Export markets | 100+ countries including US, EU, UK, Australia, Middle East, Asia Pacific |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.