FDA.reportPublic FDA data

iGrow Hair Growth System

Primary DI
20861134000106
Brand
iGrow Hair Growth System
Company
APIRA SCIENCE, INC.
Model
PE104IG00
Device description
iGrow Hair Growth System, Standard Single Unit
Published
2017-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K122248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122248000IGROW II HAIR GROWTH SYSTEMApira Science, Inc.2012-12-05OAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861134000109PackageGS16
20861134000106PackageGS12
00861134000102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086113400010910861134000109
2086113400010620861134000106
00861134000102008611340001028611340001020861134000102

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. It may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(561)465-7000ray@apirascience.com

Regulatory Flags#

DUNS number
010514721
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861134000102iGrow Hair Growth SystemPE104IG002017-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003374178LOCKrx Red Light CapRevian, Inc.OAP2026-05-18
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