FDA.reportPublic FDA data

LOCKrx Red Light Cap

Primary DI
00850003374178
Brand
LOCKrx Red Light Cap
Company
Revian, Inc.
Model
10000-10015
Catalog number
10015
Device description
The LOCKrx Red Light Cap is a hair regrowth cap.
Published
2026-05-18
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
OAPLaser, Comb, Hair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAPLaser, Comb, HairPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242441000Revian Lyte (10011)Revian, Inc.2024-09-13OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003374178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003374178008500033741788500033741780850003374178

GMDN Terms#

Term, Definition table
TermDefinition
Hair growth laser deviceAn electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Contacts#

Phone, Email table
PhoneEmail
919-229-4653support@revian.com

Regulatory Flags#

DUNS number
080259941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003374161GetHairMD10000-10013100132025-05-07
00862712000309REVIAN RED101100012019-03-29
00850003374017Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug10000-12707127072024-11-19
00850003374147Revian Inc. Replacement Kit USB-C Power Cable10000-12723127232024-11-19
008500033741162M USB Magnetic Cable v2 Only Replacement Kit10000-12720127202024-08-02
00850003374093Revian Magnetic Micro-USB Connector Only Replacement Kit10000-12718127182024-04-06
00850003374109Revian 2M USB to Magnetic MicroUSB Cable Only Replacement Kit10000-12719127192024-04-06
00850003374130Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit10000-12722127222024-04-06
00862712000316Revian AC Adaptor Replacement Kit10000-12400124002024-04-06
00862712000378REVIAN Headliner Universal Kit10000-12600126002024-04-06
00862712000392Revian Lyte10000-10011100112024-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850056575157HairStem LaserCapLaserCap CompanyOAP2026-05-01
06953808300503Laser CapHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-04-29
06953808300510Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-04-29
06953808300527Laser Therapy Hair Growth CombHubei YJT Intelligent Technology Group Co., Ltd.OAP2026-04-29
06974958310457LIFEPRO FITNESSShenzhen Idea Light LimitedOAP2026-04-17
00850523007365CellumaBiophotas, Inc.OAP2026-04-06
00860007783470Xtrallux™Xtrallux, LLCOAP2026-04-02
00860007783487Xtrallux™Xtrallux, LLCOAP2026-04-02
00860007783494Xtrallux™ Xtrallux, LLCOAP2026-04-02
00840223305984HAIRCLUB RX™Xtrallux, LLCOAP2026-03-30
00840223305991HAIRCLUB RX™Xtrallux, LLCOAP2026-03-30
00840223306004HAIRCLUB RX™Xtrallux, LLCOAP2026-03-30
00810045461571CapillusCAPILLUS, LLCOAP2026-03-01
09361725024414Bon ChargeLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDOAP2025-11-28
00810045461533CapillusCAPILLUS, LLCOAP2025-09-03
00810045461564CapillusCAPILLUS, LLCOAP2025-09-03
00810045461526CapillusCAPILLUS, LLCOAP2025-08-19
00850075326006CellumaBiophotas, Inc.OAP2025-07-24
00860007783456Xtrallux™Xtrallux, LLCOAP2025-07-01
00850049532440HIGHERDOSEShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
00850062024557EXOCEUTICALSShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
06970006970918NOOANCEShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
06970006970925NOOANCEShenzhen Kaiyan Medical Equipment Co,. LtdOAP2025-06-28
06978743639853Diode Laser CapCosmo Far East Technology LimitedOAP2025-06-26
00850003374161GetHairMDRevian, Inc.OAP2025-05-07
06975488665482BreoShenzhen Breo Technology Co., Ltd.OAP2025-01-14
06975488664256BreoShenzhen Breo Technology Co., Ltd.OAP2024-12-25
00850523007761CellumaBiophotas, Inc.OAP2024-12-23
00850523007730CellumaBiophotas, Inc.OAP2024-12-20
00810045461458CapillusCAPILLUS, LLCOAP2024-12-19