OPS600

GUDID 00816722022172

OPS600 IPL Handpiece

CUTERA, INC.

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
Primary Device ID00816722022172
NIH Device Record Key3563d388-d752-499e-895a-ecc3740af0ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPS600
Version Model NumberOPS600
Company DUNS041071643
Company NameCUTERA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com
Phone1 415 657-5500
Emailinfo@cutera.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816722022172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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