Model 20-CH W/ AR-10A/U Optical Attachment
FDA 510(k) K894241 · Directed Energy, Inc.
510(k) numberK894241
Submission
- Device name
- Model 20-CH W/ AR-10A/U Optical Attachment
- Applicant
- Directed Energy, Inc.
Los Angeles, CA, US - Received
- June 21, 1989
- Decision date
- June 18, 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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| 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 |
|---|---|---|
| K904930 | Surgical Carbon Dioxide Laser Syst Model 20-CHGEX · Traditional | 03/21/1991SE |
| K883738 | Carbon Dioxide Laser System Model 20-CX W/Attach.GEX · Traditional | 11/15/1988SE |
| K882926 | Model AU-1 Accessory UnitGEX · Traditional | 09/09/1988SE |
| K880216 | Model 20C W/An AR-10A/U & RL-20A/U for Arthroscop.GEX · Traditional | 03/04/1988SE |
| K873331 | Ortho. Gas Insufflator Model IN-2 for Arthro. SurgHRX · Traditional | 02/17/1988SE |
| K872709 | Model 20-C, RL-20A/U, OB-10A/UHHR · Traditional | 02/02/1988SE |
| K870841 | Model 20-C W/BR-20A/U Attach/Model HL-3.0 OB/GYNHHR · Traditional | 02/02/1988SE |
| K872711 | Model 20-C W/AR-10A/U Attach. for Arthro. SurgeryGEX · Traditional | 09/28/1987SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | 09/24/1987SE |
| K870840 | Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional | 06/12/1987SE |
Questions and answers
When was Model 20-CH W/ AR-10A/U Optical Attachment cleared by the FDA?
Model 20-CH W/ AR-10A/U Optical Attachment (K894241) received a 510(k) decision of Substantially Equivalent on June 18, 1990, 362 days after the submission was received.
What is the product code of K894241?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.