FDA.report

carevia

Primary DI
06978874940033
Brand
carevia
Company
Alovea Healthcare Co., Ltd.
Model
I6 D1
Device description
IPL Hair Removal Device
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OHTLight Based Over-The-Counter Hair Removal

Product Code Classifications

CodeDeviceSpecialtyClass
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K252618000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K252618000IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)Alovea Healthcare Co. , Ltd.2025-11-14OHT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06978874940033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06978874940033069788749400336978874940033

GMDN Terms

TermDefinition
Home-use intense pulsed light hair removal unitA hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.

Sterilization Methods

Method

Regulatory Flags

DUNS number
450425100
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06978874940019careviaI6 M12025-12-17
06978874940026careviaI6 S12025-12-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06970024710916semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024710947semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024710954semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024710961semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024710978semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024710985semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024710992semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024711005semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024711050semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024711074semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024711081semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06970024711098semlampShenzhen Semlamp Intelligent Technology Co., LtdOHT2026-05-26
06978874940019careviaAlovea Healthcare Co., Ltd.OHT2025-12-17
06978874940026careviaAlovea Healthcare Co., Ltd.OHT2025-12-17
16974667827144UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827151UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827168UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827564UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827571UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827588UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827595UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827601UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827618UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827625UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827632UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
06974667827642UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827656UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827663UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
06974667827673UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10
16974667827687UlikeShenzhen Ulike Smart Electronics Co., Ltd.OHT2025-12-10