Vbeam
GUDID 00817495020433
Pulsed Laser
CANDELA CORPORATION
Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system Dermatological dye laser system| Primary Device ID | 00817495020433 |
| NIH Device Record Key | 4d25f7bf-1c2d-43a2-a25f-02a09dc377c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vbeam |
| Version Model Number | 9914-00-0720 |
| 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 | false |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495020433 [Primary] |
| GS1 | 08174950200437 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K230990
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 | 4 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Vbeam ]
| 08174950201373 | Pulsed Laser |
| 08174950200314 | Pulsed Laser |
| 08174950200307 | Pulsed Laser |
| 00817495021584 | Pulsed Laser |
| 00817495020433 | Pulsed Laser |
Trademark Results [Vbeam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VBEAM 75893036 2515791 Live/Registered |
Candela Corporation 2000-01-10 |
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