Portalase 300 Carbon Dioxide Surg Laser Neurologic
FDA 510(k) K854473 · Minnesota Laser Corp.
510(k) numberK854473
Submission
- Device name
- Portalase 300 Carbon Dioxide Surg Laser Neurologic
- Applicant
- Minnesota Laser Corp.
Minneapolis, MN, US - Received
- November 6, 1985
- Decision date
- June 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
Other 510(k)s with product code GEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874255 | Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional | 07/12/1988SE |
| K874253 | Nd:Yag Surgical Laser for Gastro/Urology Applica.LNK · Traditional | 07/12/1988SE |
| K874254 | Nd:Yag Surgical Laser for Pulmonary ApplicationsLLO · Traditional | 03/04/1988SE |
| K854468 | Portalase 200 Carbon Dioxide Surg Laser NeurologicGEX · Traditional | 06/20/1986SE |
| K854471 | Portalase 300 Carbon Dioxide Surg Laser Ear/Nose/TEWG · Traditional | 02/13/1986SE |
| K854472 | Portalase 300 Carbon Dioxide Surg Laser DermatologGEX · Traditional | 02/11/1986SE |
| K854469 | Portalase 200 Carbon Dioxide Surg Laser DermatologGEX · Traditional | 02/11/1986SE |
| K854470 | Portalase 300 Carbon Dioxide Surg Laser GynecologiHHR · Traditional | 02/07/1986SE |
| K852694 | Portalase 200 Carbon Surgical Laser SystemHHR · Traditional | 09/30/1985SN |
| K852696 | For Use in General & Plastic Surgery & DermatologyGEX · Traditional | 09/19/1985SE |
Questions and answers
When was Portalase 300 Carbon Dioxide Surg Laser Neurologic cleared by the FDA?
Portalase 300 Carbon Dioxide Surg Laser Neurologic (K854473) received a 510(k) decision of Substantially Equivalent on June 20, 1986, 226 days after the submission was received.
What is the product code of K854473?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.