FDA.reportPublic FDA data

Tip ClearLift QS KTP 532 3mm (Female)

Primary DI
17290110122253
Brand
Tip ClearLift QS KTP 532 3mm (Female)
Company
ALMA LASERS LTD.
Model
1
Catalog number
AACL01062120
Published
2021-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTCLight, Ultraviolet, Dermatological
GEXPowered Laser Surgical Instrument
HHRLaser, Surgical, Gynecologic
LNKLaser For Gastro-Urology Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTCLight, Ultraviolet, DermatologicalGeneral, Plastic Surgery2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HHRLaser, Surgical, GynecologicObstetrics/Gynecology2
LNKLaser For Gastro-Urology UseGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072564000ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORMAlma Lasers , Ltd.2008-05-23GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110122253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012225317290110122253

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283264
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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