FDA Device Registration & Listing · Bothell, WA, US · Registration 3011423170
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2011-11-07 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2016-06-20 |
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | Class 2 | 878.5040 | 2013-10-25 |
| ISA | Massager, Therapeutic, Electric | Physical Medicine | Class 1 | 890.5660 | 2016-06-24 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-06-24 |
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | Class 2 | 878.5040 | 2019-12-19 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2015-10-26 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2025-01-22 |
| ISA | Massager, Therapeutic, Electric | Physical Medicine | Class 1 | 890.5660 | 2017-09-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-09-28 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | General, Plastic Surgery | Class 2 | 878.4810 | 2010-12-29 |
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | Class 2 | 878.5040 | 2013-05-07 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2011-01-21 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2017-01-09 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | General, Plastic Surgery | Class 2 | 878.4810 | 2013-06-12 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | General, Plastic Surgery | Class 2 | 878.4810 | 2011-08-26 |
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | Class 2 | 878.5040 | 2016-01-14 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2009-03-11 |
| ISA | Massager, Therapeutic, Electric | Physical Medicine | Class 1 | 890.5660 | 2010-12-29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2010-12-29 |
| QPB | System, Suction, Lipoplasty For Removal | General, Plastic Surgery | Class 2 | 878.5040 | 2019-12-23 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | General, Plastic Surgery | Class 2 | 878.4810 | 2023-01-20 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2023-01-20 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K083258 | Dornier Medtech America, Inc. | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | 2009-01-30 |
| K201111 | Candela Corporation | GentleMax Pro Plus | 2020-05-26 |
| K202758 | Shangdong Huamei Technology Co., Ltd. | Nd: YAG Laser Therapy Systems HM-YL900 | 2020-11-16 |
| K904068 | Luxar Corp. | LUXAR MODEL LX-20 CO2 LASER | 1991-04-15 |
| K142225 | CAO Group, Inc. | Pilot Elite Diode Laser | 2014-09-12 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0005-2014 | PhotoMedex, Inc. | 2 | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***.
The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081.
Indicated for the incision, excision, coagulations, and vaporization of soft tissue. |
| Z-0025-2018 | Medtronic Navigation, Inc. | 2 | VCLAS (Visualase Cooled Laser Ablation System)
Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;
Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;
Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip |
| Z-0028-2007 | Lumenis Inc. | 2 | Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA |
| Z-0031-06 | Rita Medical Systems | 2 | Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;
Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1725006 | CAO GROUP, INC. | W Jordan, UT, US |
| 2133641 | BENCHMARK ELECTRONICS, INC. | WINONA, MN, US |
| 3015889734 | SOFWAVE MEDICAL LTD. | Yokneam Illit Northern, IL |
| 1313525 | Bausch & Lomb Incorporated | Rochester, NY, US |
| 3013840437 | Merz North America, Inc. | Sturtevant, WI, US |
3011423170 when referencing this establishment in official correspondence.