FDA.reportPublic FDA data

SR515 applicator

Primary DI
07290016540505
Brand
SR515 applicator
Company
VENUS CONCEPT LTD
Model
AS120033
Device description
• Treatment of benign pigmented epidermal and cutaneous lesions including: dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, n
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153717000Venus Versa SystemVenus Concept , Ltd.2016-03-21ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016540505PackageGS11In Commercial Distribution
07290016540390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016540505072900165405057290016540505
07290016540390072900165403907290016540390

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
533127663
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016540765Venus Legacy CX - LB2 applicator (new design)AS1000632018-11-18
07290016540963Venus Legacy CX - LF2 applicator (new design)AS1000752018-11-18
07290016541281BLISS SYSTEMBL0000012021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissSPK1600002021-07-14
07290016541618(MP)2 APPLICATOR BLISSAS1600432021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissSPK1600012021-07-14
07290016540000Venus LegacyLE1200042016-09-24
07290016540055Venus Legacy kitPK0000082016-09-24
07290016540079LB1 + LF1 kitPK0000412016-09-24
07290016540086Venus Legacy - 110V SystemLE1000042018-11-18
07290016540109Venus Legacy LE2400042016-09-24
07290016540116Venus Legacy kitPK0000022016-09-24
07290016541472Venus Legacy 240V - NikaoAS100005NI2018-11-18
07290016541533Venus Legacy 110V - NikaoLE120004NI2018-11-18
07290016541984Epileve Applicator Service Pack UDI LabelSPK2300102021-07-14
27290016541179HR 690XL Light Block packagePK0003242020-04-23
27290016541216HR690 Light Block packagePK0003282020-04-23
27290016541223ACDUAL Light Block packagePK0003442020-04-23
07290016541168Venus Versa - HR 650XL light block packagePK0003232018-11-18
07290016541182Venus Versa - SR515 light block packagePK0003252018-11-18

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00850062978003WORLD AESTHETIX BROAD PULSED LIGHTWORLD AESTHETIX LLCONF2024-06-25