FiberLase™ HP-R 140 mm bent, straight tip
GUDID 07290109141152
LUMENIS LTD.
General/multiple surgical solid-state/carbon dioxide laser system| Primary Device ID | 07290109141152 |
| NIH Device Record Key | 11b2d338-31b6-45c9-b45d-0d80d924bd33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FiberLase™ HP-R 140 mm bent, straight tip |
| Version Model Number | FiberLase™ HP-R 140 mm bent, straight tip |
| 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 | true |
| 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 | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx | |
| Phone | 408-764-3000 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290109141152 [Primary] |
| GS1 | 07290109143828 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100384
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
[07290109141152]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2016-08-25 |
Devices Manufactured by LUMENIS LTD.
| 07290109147161 - Lumenis Pulse 120H | 2025-02-26 |
| 07290109147178 - Lumenis Pulse 120H | 2025-02-26 |
| 07290109147185 - Lumenis Pulse, Moses 2.0 (DOM) | 2025-02-26 |
| 07290109147192 - Lumenis Pulse 120H | 2025-02-26 |
| 07290109147208 - Lumenis Pulse, Moses 2.0 (INT) | 2025-02-26 |
| 07290109147215 - Lumenis Pulse 120H | 2025-02-26 |
| 07290109147222 - Lumenis Pulse 120H | 2025-02-26 |
| 07290109147291 - Lumenis Pulse 120H | 2025-02-26 |
Trademark Results [FiberLase]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBERLASE 74372304 1805940 Dead/Cancelled |
Surgilase Inc. 1993-03-26 |
 FIBERLASE 74343254 1789262 Dead/Cancelled |
SHARPLAN LASERS, INC. 1992-12-23 |
 FIBERLASE 73618737 not registered Dead/Abandoned |
GENERAL FIBER OPTICS, INC. 1986-09-08 |
 FIBERLASE 73403853 1300403 Dead/Cancelled |
Barr & Stroud Limited 1982-11-23 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.