FDA.report

Foundation Light Therapy LaserCap

Primary DI
00850056575119
Brand
Foundation Light Therapy LaserCap
Company
LaserCap Company
Model
00850056575119
Catalog number
00850056575119
Device description
Foundation Light Therapy LaserCap
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OAPLaser, Comb, Hair

Product Code Classifications

CodeDeviceSpecialtyClass
OAPLaser, Comb, HairPhysical Medicine2

Premarket Submissions

SubmissionSupplement
K203826000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K203826000LaserCap Family of Lasers 300, 224, 120 & 80Transdermal Cap, Inc.2021-03-29OAP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850056575119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056575119008500565751198500565751190850056575119

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
855-424-7774info@lasercap.com

Regulatory Flags

DUNS number
056706029
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
00850056575003LaserCap HD+00850056575003008500565750032023-09-08
00850056575010LaserCap HD00850056575010008500565750102023-09-08
00850056575027LaserCap SD00850056575027008500565750272023-09-08
00850056575034LaserCap HD XL00850056575034008500565750342023-09-08
00850056575041LaserCap MC200850056575041008500565750412023-09-08
00850056575058Turbo LaserCap00850056575058008500565750582023-09-08
00850056575065Medi Tresse LaserCap HD+00850056575065008500565750652023-09-08
00850056575072Medi Tresse LaserCap HD00850056575072008500565750722023-09-08
00850056575089V8 LaserCap 00850056575089008500565750892023-09-08
00850056575096ZCap00850056575096008500565750962023-09-08
00850056575102Maxim LaserCap00850056575102008500565751022023-09-08
00850056575126Foundation Light Therapy Optima LaserCap00850056575126008500565751262023-09-08
00850056575133Get Hair MD LaserCap00850056575133008500565751332023-09-08
00850056575140CURE LaserCap00850056575140008500565751402023-09-08

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