LED Lip Perfector, model: ZC-05
FDA 510(k) K223642 · Light Tree Ventures Europe B.V.
510(k) numberK223642
Submission
- Device name
- LED Lip Perfector, model: ZC-05
- Applicant
- Light Tree Ventures Europe B.V.
Hague, NL - Received
- December 6, 2022
- Decision date
- March 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Other 510(k)s with product code ILY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…ILY · Traditional | Wuhan PHOMED Technology Company , Ltd. | 03/19/2026SE |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…ILY · Traditional | Gigaalaser Company , Ltd. | 05/19/2025SE |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)ILY · Traditional | Cure Point Therapeutics, Inc. | 10/15/2024SE |
| K221189 | Oliz LTB-1000AILY · Traditional | Ltbio Co., Ltd. | 08/29/2022SE |
| K213524 | CytonPro-5000ILY · Traditional | Cytonsys, Inc. | 08/10/2022SE |
| K202028 | dermalux Flex MDILY · Traditional | Aesthetic Technology, Ltd. | 12/16/2020SE |
| K171087 | AXON IR Heat LampILY · Traditional | Crystal Medtech, LLC | 07/07/2017SE |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM…ILY · Traditional | Healthlight, LLC | 06/13/2017SE |
| K170068 | Softcure 96ILY · Traditional | Wellray Medical Laser, Inc. | 05/05/2017SE |
| K162590 | Bashan TDP Heat LampILY · Traditional | Chogqing Yuhe Medical Instruments Co., Ltd. | 02/14/2017SE |
More from Chogqing Yuhe Medical Instruments Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260415 | myLEDmask 2 (MJ-144)OHS · Traditional | 05/12/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | 12/24/2025SE |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001OLP · Traditional | 07/03/2023SE |
| K223893 | Infrared Heat (Model: E0221)OHS · Traditional | 05/16/2023SE |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)OAP · Traditional | 04/28/2023SE |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023)OHS · Traditional | 04/28/2023SE |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07)OAP · Traditional | 04/05/2023SE |
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)OHS · Traditional | 03/15/2023SE |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)OHS · Traditional | 12/20/2022SE |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36BOHS · Traditional | 12/08/2022SE |
Questions and answers
When was LED Lip Perfector, model: ZC-05 cleared by the FDA?
LED Lip Perfector, model: ZC-05 (K223642) received a 510(k) decision of Substantially Equivalent on March 9, 2023, 93 days after the submission was received.
What is the product code of K223642?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.