Minuteman CO2 Microsurgical Laser Oto
FDA 510(k) K843514 · American Surgical Laser, Inc.
510(k) numberK843514
Submission
- Device name
- Minuteman CO2 Microsurgical Laser Oto
- Applicant
- American Surgical Laser, Inc.
Woburn, MA, US - Received
- September 5, 1984
- Decision date
- December 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWG – Laser, Ent Microsurgical Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
| K924652 | Benson CCA100EWG · Traditional | Benson Medical Instruments Co. | 04/09/1993SE |
| K870587 | Lasermatic Surgilaser Model 5050EWG · Traditional | Lasermatic OY | 08/10/1988SN |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | Directed Energy, Inc. | 09/24/1987SE |
| K870840 | Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional | Directed Energy, Inc. | 06/12/1987SE |
| K864975 | Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional | Laserscope | 02/25/1987SE |
| K862866 | Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862865 | Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
More from Directed Energy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843515 | Minuteman CO2 Microsurgical Laser GynHHR · Traditional | 02/04/1985SE |
| K843519 | Minuteman CO2 Microsurg Laser Gen SurgGEY · Traditional | 12/07/1984SE |
| K843518 | Minuteman C02 Microsurg Laser PodiatryGEY · Traditional | 12/07/1984SE |
| K843517 | Minuteman CO2 Microsurg Laser Dermatol-GEY · Traditional | 12/07/1984SE |
Questions and answers
When was Minuteman CO2 Microsurgical Laser Oto cleared by the FDA?
Minuteman CO2 Microsurgical Laser Oto (K843514) received a 510(k) decision of Substantially Equivalent on December 4, 1984, 90 days after the submission was received.
What is the product code of K843514?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.