FDA.reportPublic FDA data

CurrentBody Skin™

Primary DI
00860011935599
Brand
CurrentBody Skin™
Company
Shenzhen Kaiyan Medical Equipment Co,. Ltd
Model
MZ-07AL
Device description
The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who haveNorwood-Hamilton classifications of la-V or females with who have Ludwig-Savin Classifications of I-II and both withFitzpatrick Skin Phototypes I-IV.
Published
2026-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OAPLaser, Comb, Hair

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011935599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011935599008600119355998600119355990860011935599

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.

Regulatory Flags#

DUNS number
543062382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00731093153129CurrentBody Skin™MZ-07M2026-06-27
00850079561014CurrentBody Skin™ZLD-72B2026-06-27
00860011935582CurrentBody Skin™MZ-07AM2026-06-27
06970006973285CurrentBody Skin™MZ-07L2026-06-27
00850049532440HIGHERDOSEHG-120K2025-06-28
00731093153136CurrentBody Skin™MZ-072024-01-30
00695866567110CurrentBody Skin™EY-36B2025-06-28
00810137610429SOLAWAVEEY-20N2025-06-28
00810137610436SOLAWAVE610432025-06-28
00850049532471HIGHERDOSEMK66-L2025-06-28
00850062024557EXOCEUTICALSSZ-22A2025-06-28
00856957008022Dr NaomiMK-042025-06-28
05060282690301LustrePR60012025-06-28
05060282690318LustrePR50012025-06-28
06970006970918NOOANCEM-2822025-06-28
06970006970925NOOANCEM-1202025-06-28
06970006971144CosmotologyEY-20R2025-06-28
06970006971212EnergyLoungerTY-012025-06-28
00843041136433Tommie copper5008LD2022-01-26
00843041136907Tommie Copper5010LD2022-01-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974958310587ideatherapyShenzhen Idea Light LimitedOAP2026-07-09
06977638360483Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09
06977638360612Hair Growth DeviceDongguan Boyuan Intelligent Technology Co.,LtdOAP2026-07-09
00731093153129CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00850079561014CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
00860011935582CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
06970006973285CurrentBody Skin™Shenzhen Kaiyan Medical Equipment Co,. LtdOAP2026-06-27
05061091983134Beauty PieLIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITEDOAP2026-06-23
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