AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade
GUDID 07290109142944
LUMENIS LTD.
General/multiple surgical solid-state/carbon dioxide laser system| Primary Device ID | 07290109142944 |
| NIH Device Record Key | 8eb61fcd-64a7-4702-81ea-91384d552a31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade |
| Version Model Number | AcuPulse™ Upgrade Kit to AES-R 4 Modes Upgrade |
| Company DUNS | 600166524 |
| Company Name | LUMENIS LTD. |
| 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 | false |
| 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 | 408-764-3000 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109142944 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100415
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 | 2018-07-06 |
| Device Publish Date | 2016-09-14 |
Devices Manufactured by LUMENIS LTD.
| 07290118853701 - Lumenis Pulse 60H, 60Hz | 2023-12-18 |
| 07290109144924 - Stellar SapphireCool LG 6mm | 2023-08-16 |
| 07290109144931 - Stellar SapphireCool LG 15x35 | 2023-08-16 |
| 07290109144948 - Stellar SapphireCool LG 8x15 | 2023-08-16 |
| 07290109146676 - SurgiTouch Scanner | 2022-09-30 |
| 07290109146133 - UltraPulse® DUO | 2022-09-28 UltraPulse DUO |
| 07290109147055 - VersaPulse PowerSuite 80/100W | 2022-09-27 |
| 07290109147062 - VersaPulse PowerSuite 80/100W | 2022-09-27 |
Trademark Results [AcuPulse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACUPULSE 85331090 4080128 Dead/Cancelled |
ACUPOLL RESEARCH, INC. 2011-05-26 |
 ACUPULSE 75663817 2332207 Dead/Cancelled |
AcuPOLL Precision Research 1999-03-19 |
 ACUPULSE 74541836 not registered Dead/Abandoned |
Acunetics Corporation 1994-06-24 |
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