PicoWay Zoom Handpiece Kit

GUDID 00817495023106

Handpiece Kit

CANDELA CORPORATION

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece

Primary Device ID	00817495023106
NIH Device Record Key	2dd69de3-2e59-42f0-a745-76534e786aa0
Commercial Distribution Status	In Commercial Distribution
Brand Name	PicoWay Zoom Handpiece Kit
Version Model Number	7123-00-0637
Company DUNS	053468385
Company Name	CANDELA CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817495023106 [Primary]
GS1	08174950203100 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191685
Premarket Notification: K220853

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-08-03
Device Publish Date	2020-01-03

On-Brand Devices [PicoWay Zoom Handpiece Kit]

08174950203100	Handpiece Kit
00817495023106	Handpiece Kit