Genesis 2000
FDA 510(k) K944206 · Ion Laser Technology
510(k) numberK944206
Submission
- Device name
- Genesis 2000
- Applicant
- Ion Laser Technology
Salt Lake City, UT, US - Received
- August 29, 1994
- Decision date
- October 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K974369 | Apollo 9500EBZ · Traditional | 01/06/1998SE |
| K964524 | Ilt Argon HPEBZ · Traditional | 03/18/1997SE |
| K953898 | ACL-5500 Precision Curing Unit (Pcu)EBZ · Traditional | 02/15/1996SE |
| K954460 | Ilt Surgical LaserGEX · Traditional | 12/18/1995SE |
| K950351 | CL-5500 (Unmodified Device) Precision Curing Unit (Pcu) (Modified Option)GEX · Traditional | 03/24/1995SE |
| K944317 | Genesis 2000GEX · Traditional | 10/11/1994SE |
| K915656 | Carbon Dioxide CO2 LaserGEX · Traditional | 04/10/1992SE |
| K914726 | Ilt CO2 Surgical Laser for Oral Soft Tissue ProcedGEX · Traditional | 12/17/1991SE |
Questions and answers
When was Genesis 2000 cleared by the FDA?
Genesis 2000 (K944206) received a 510(k) decision of Substantially Equivalent on October 11, 1994, 43 days after the submission was received.
What is the product code of K944206?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.