FDA.report

IPL-Sq

Primary DI
07898961835020
Brand
IPL-Sq
Company
VYDENCE MEDICAL
Model
18077
Catalog number
18077
Device description
IPL-Sq
Published
2024-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications

CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K171443000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K171443000Etherea MXVydence Medical Industria E Comercio Ltda2018-04-20GEX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898961835020PrimaryGS10

GMDN Terms

TermDefinition
Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+551633065050sac@vydence.com

Regulatory Flags

DUNS number
904013281
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
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

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