MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 Nd:Yag
FDA 510(k) K903444 · Heraeus Lasersonics, Inc.
510(k) numberK903444
Submission
- Device name
- MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 Nd:Yag
- Applicant
- Heraeus Lasersonics, Inc.
Milpitas, CA, US - Received
- July 27, 1990
- Decision date
- October 11, 1990
- 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 |
|---|---|---|
| K933245 | Ultraline II Sterile Disposable FiberGEX · Traditional | 04/21/1994SE |
| K923896 | Hercules Model 5060 and 5100 Nd:Yag Laser SystemsGEX · Traditional | 11/25/1992SE |
| K921807 | Ultraline Sterile Disposable FiberGEX · Traditional | 06/18/1992SE |
| K915578 | Nd;Yag Surgical Laser SystemsGEX · Traditional | 06/15/1992SE |
| K915583 | CO2 Laser and Waveguide Delivery Systems for Thor.GEX · Traditional | 03/27/1992SE |
| K912618 | Laser Systems for Percutaneous Lumbar DiscectomyGEX · Traditional | 02/27/1992SE |
| K913887 | C02 Laser WaveguideGEX · Traditional | 12/09/1991SE |
| K910530 | Carbon Dioxide Laser Systems W/Waveguide DeliveryGEX · Traditional | 10/31/1991SE |
| K913918 | Heraeus Lasersonics Tactilase Sterile Dispos FiberGEX · Traditional | 09/25/1991SE |
| K913564 | Hercules 5000 and Hercules 5040 Nd:Yag Laser SysteGEX · Traditional | 09/16/1991SE |
Questions and answers
When was MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 Nd:Yag cleared by the FDA?
MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 Nd:Yag (K903444) received a 510(k) decision of Substantially Equivalent on October 11, 1990, 76 days after the submission was received.
What is the product code of K903444?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.