Opelaser

GUDID 04547497771052

YOSHIDA DENTAL MFG. CO., LTD., THE

Dermatological carbon dioxide laser system

Primary Device ID	04547497771052
NIH Device Record Key	c4472e37-b1c0-4f28-bac0-eae3ddd9bce4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Opelaser
Version Model Number	Opelaser PROⅡ
Company DUNS	690676978
Company Name	YOSHIDA DENTAL MFG. CO., LTD., THE
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	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp
Phone	+81336312165
Email	yoshida4export-kokusai@yoshida-net.co.jp

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547497771052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120932

FDA Product Code

GEX	Powered Laser Surgical Instrument