Lasermatic Combolaser Model 5050
FDA 510(k) K895279 · Lasermatic OY
510(k) numberK895279
Submission
- Device name
- Lasermatic Combolaser Model 5050
- Applicant
- Lasermatic OY
North Attleboro, MA, US - Received
- August 24, 1989
- Decision date
- November 8, 1989
- 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 |
|---|---|---|
| K903131 | Lasermatic Supercombo(Tm) Surgical Laser SystemGEX · Traditional | 02/19/1991SE |
| K901638 | Modified Combolaser 5050 & New Model 5050 Ver. 33GEX · Traditional | 06/27/1990SE |
| K893529 | Combolaser Model 5050GEX · Traditional | 06/08/1989SE |
| K871875 | Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional | 08/22/1988SE |
| K870587 | Lasermatic Surgilaser Model 5050EWG · Traditional | 08/10/1988SN |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional | 03/25/1988SE |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | 03/25/1988SE |
| K871933 | Model 5050 Surgilaser for Neurosurgery UseGEX · Traditional | 01/22/1988SE |
| K871876 | Model 5050 Surgilaser for Pulmonary UseLLO · Traditional | 01/22/1988SE |
Questions and answers
When was Lasermatic Combolaser Model 5050 cleared by the FDA?
Lasermatic Combolaser Model 5050 (K895279) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 76 days after the submission was received.
What is the product code of K895279?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.