FDA.reportPublic FDA data

semlamp

Primary DI
06970024710985
Brand
semlamp
Company
Shenzhen Semlamp Intelligent Technology Co., Ltd
Model
SL-B352-2
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OHTLight Based Over-The-Counter Hair Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260518000IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)Shenzhen Semlamp Intelligent Technology Co., Ltd.2026-04-21OHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970024710985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970024710985069700247109856970024710985

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
403814543
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970024710916semlampSL-B3302026-05-26
06970024710947semlampSL-B330-12026-05-26
06970024710954semlampSL-B287-12026-05-26
06970024710961semlampSL-B3522026-05-26
06970024710978semlampSL-B352-12026-05-26
06970024710992semlampSL-B3712026-05-26
06970024711005semlampSL-B371-12026-05-26
06970024711050semlampSL-B371-22026-05-26
06970024711074semlampSL-B3002026-05-26
06970024711081semlampSL-B3012026-05-26
06970024711098semlampSL-B330-F2026-05-26
06970024714051semlampSL-B3292025-12-02
06970024710169semlampSL-B0802024-12-17
06970024710176semlampSL-B1262024-12-17
06970024710183semlampSL-B1362024-12-17
06970024710374semlampSL-B2872024-12-17
06970024710558semlampSL-B3292024-12-17
06970024710671semlampSL-B301-12024-12-17
06970024710886semlampSL-B3282024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
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
06978874940033careviaAlovea 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