FDA.reportPublic FDA data

VBEAM Prima without Contact Cooling or 1064 nm

Primary DI
08174950202936
Brand
VBEAM Prima without Contact Cooling or 1064 nm
Company
CANDELA CORPORATION
Model
9914-00-9081
Device description
Pulsed Laser
Published
2019-12-12
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

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
K183452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183452000Vbeam Prima Laser SystemCandela Corp.2019-02-01GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08174950202936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08174950202936081749502029368174950202936

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological dye laser systemA mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite organic compounds (i.e., dye) used as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation to incise, excise, ablate, and vaporize soft tissues for dermatological applications such vascular/skin lesion, acne and wrinkle removal or reduction. It typically includes a light source, flexible fibreoptic delivery/positioning device(s), and controls/foot-switch for pulsed mode operation. During emission the dye has to be optically excited by another light source (e.g., another laser or flash lamp).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-733-8550customer.service@candelamedical.com

Regulatory Flags#

DUNS number
053468385
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817495025070Refurbished Applicator 1550 FIN1012082025-05-20
00817495025087Refurbished Applicator 1940FIN1012072025-05-20
00817495024622Glace SBA1038402025-10-07
00817495025292Glace SBA1038782025-10-07
00817495025308Glace SBA1038892025-10-07
00817495025315Glace SBA1039002025-10-07
00817495025339Glace FIN1029552025-10-07
00817495025346Glace FIN1029562025-10-07
00817495025353Glace FIN1029572025-10-07
00817495025360Glace FIN1044922025-10-07
00817495025377Glace FIN1047562025-10-07
00817495025384Glace FIN1045952025-10-07
00817495025391Glace FIN1045942025-10-07
00817495025407Glace MCN1037982025-10-07
00817495025414Glace FIN1029382025-10-07
00817495025421Glace FIN1029422025-10-07
00817495025438Glace FIN1029542025-10-07
008174950244005-Pk, external hygienic, CO2RE IntimaKT76685KT766852023-10-20
00817495024424Handpiece, external CO2RE IntimaAS90245AS902452023-10-20
00817495024431Purple Swivel Lens CO2REAS90411AS904112023-10-20

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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16