Emvera
GUDID 00863267000318
Hand piece to be used with the Emvera Diolux Hair Removal Laser
EMVERA TECHNOLOGIES, LLC
Dermatological diode laser system| Primary Device ID | 00863267000318 |
| NIH Device Record Key | 7586cd79-6d20-44fc-9266-5f6d20cee78f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Emvera |
| Version Model Number | Diolux Hand piece |
| Company DUNS | 079501638 |
| Company Name | EMVERA TECHNOLOGIES, LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com | |
| Phone | 1-888-886-8402 |
| info@emvera.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863267000318 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123257
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 | 3 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2016-11-28 |
On-Brand Devices [Emvera]
| 00863267000318 | Hand piece to be used with the Emvera Diolux Hair Removal Laser |
| 00863267000301 | 808nm Diode Hair Removal Laser System Body |
Trademark Results [Emvera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMVERA 86095667 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095658 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095656 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095652 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095643 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095638 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095633 4886342 Live/Registered |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095626 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
 EMVERA 86095619 not registered Dead/Abandoned |
Emvera Technologies, LLC 2013-10-18 |
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