FDA.reportPublic FDA data

Laserconn

Primary DI
06972558160045
Brand
Laserconn
Company
Sanhe Laserconn Tech Co., Ltd.
Model
Milestone Standard-A
Catalog number
Diode Laser Hair Removal System
Device description
Diode Laser Hair Removal Systems for Medical Use-Milestone Standard-A is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222800000Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)Sanhe Laserconn Tech Co., Ltd.2022-11-07GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972558160042PackageGS11In Commercial Distribution
06972558160045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697255816004216972558160042
06972558160045069725581600456972558160045

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological laser beam guiding handpieceA hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height888Millimeter
Length388Millimeter
Width379Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
17729996108ge@3dstocking.com

Regulatory Flags#

DUNS number
560439500
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972558160038LaserconnMilestone Smart-MDiode Laser Hair Removal System2022-12-13
06972558160021LaserconnTheralasLaser Therapy System2021-06-28
16972558160028LaserconnTheralasLaser Therapy System2021-06-28

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Primary DI, Brand, Company table
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