FDA.reportPublic FDA data

ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female

Primary DI
17290110122239
Brand
ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female
Company
ALMA LASERS LTD.
Model
1
Catalog number
EGGG29112199
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
17290110122239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012223917290110122239

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

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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17290110122109Hybrid System 70W 120V 50/60 HZ 1AACO15061980BDAZ00032021-07-11
17290110122116ProScan Applicator for Hybrid System1AACO051119602021-07-11
17290110122123Pixel CO2 7x7 & 9x9 Applicator for Hybrid System1AACO280319272021-07-11
17290110122130HyLight 50 VSS Applicator for US Hybrid System1AACO090321802021-07-11
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17290110120952CO2 New Scanner system 100-120V 30W1AACO010212032016-09-24
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17290110121621Trio Diode Laser Module1AASP02031601 2018-09-16
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07290110123888CO2 LiteScan Applicator FOR INC1AACO030925012025-09-21
07290110122317Accent Prime System 120V For Inc.1AAAP07042201BA00012022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.1AAAP070422112022-11-22
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