Vasculase(R) Copper Vapor Laser Syst, Pigment Les
FDA 510(k) K903883 · Metatech Corp.
510(k) numberK903883
Submission
- Device name
- Vasculase(R) Copper Vapor Laser Syst, Pigment Les
- Applicant
- Metatech Corp.
Mountain View, CA, US - Received
- August 22, 1990
- Decision date
- September 19, 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…
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| 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 |
|---|---|---|
| K033077 | Easytem Duo, Forehead/Ear Thermometer, Model BT-021FLL · Traditional | 04/30/2004SE |
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| K020520 | Easytem Ear Thermometer, Model BT-020FLL · Traditional | 08/06/2002SE |
| K924314 | Mobile Standing FrameIPL · Traditional | 02/12/1993SE |
| K915370 | Copper Vapor Laser SystemGEX · Traditional | 02/07/1992SE |
| K890865 | Hexascan Scanner HandpieceGEX · Traditional | 03/24/1989SE |
| K883541 | Metalaser VasculaseGEX · Traditional | 11/04/1988SE |
| K883881 | Modified Model 2001 Fiber Optics CatheterGWM · Traditional | 10/27/1988SE |
| K883518 | Event Marker & a Second Pressure Trend OutputGWM · Traditional | 09/22/1988SE |
| K882552 | Metatech Robinson Bolt AccessoryGWM · Traditional | 09/08/1988SE |
Questions and answers
When was Vasculase(R) Copper Vapor Laser Syst, Pigment Les cleared by the FDA?
Vasculase(R) Copper Vapor Laser Syst, Pigment Les (K903883) received a 510(k) decision of Substantially Equivalent on September 19, 1990, 28 days after the submission was received.
What is the product code of K903883?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.