FDA.reportPublic FDA data

7LS

Primary DI
00031262096265
Brand
7LS
Company
FKA DISTRIBUTING CO., LLC
Model
FA7-1450J
Catalog number
FA7-1450J
Device description
ReNew Light Therapy
Published
2020-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162098000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162098000LED Phototherapy DeviceLi-Tek Electronic Technology Corporation2017-01-30OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00031262096265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262096265000312620962650312620962650031262096265

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248-863-3176cservice@7LSbeauty.com

Regulatory Flags#

DUNS number
183280973
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850087184007HomedicsSPE-RLWS130J2026-08-01
00850087184045HomedicsTENS-150J-CA2026-07-31
00860015688989HomedicsSPE-RLW255J2026-08-01
00860015688996HomedicsSPE-RLW135J2026-08-01
00850087184038HomedicsIFR-571HJ-CA2026-07-13
00860015688927HomedicsTIE-050-BABY2026-05-31
00031262100207HOMEDICSHP-G42AJ2020-08-31
00031262114938HOMEDICSSR-GA800J-WMT2024-06-20
00031262114945HOMEDICS SR-GHD800J-WMT2024-06-20
00031262114952HOMEDICS SR-GKM800J-WMT2024-06-20
00031262111975HOMEDICSSR-GHN800J2024-05-01
00031262111982HOMEDICS SR-GHD800J2024-05-01
00031262112002HOMEDICSSR-GA800J2024-05-01
00031262112026HOMEDICSSR-GEM700J2024-05-01
00031262112088HOMEDICSSR-GKM800J2024-05-01
00031262115874HomedicsSCL-XBC200-BK2025-01-25
00031262115898HomedicsSCL-XBC200-WT2025-01-25
00031262115904HomedicsSCL-BBC200-BK2025-01-25
00031262115911HomedicsSCL-BBC200-WT2025-01-25
00031262115959HomedicsSCL-BBC250-BK2025-01-25

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Primary DI, Brand, Company table
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00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OHS2026-07-30
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00810140063090RenphoJoicom CorporationOHS2026-06-23
00810140063090RenphoJoicom CorporationOLP2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356646390Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02