Minuteman CO2 Microsurg Laser Dermatol-
FDA 510(k) K843517 · American Surgical Laser, Inc.
510(k) numberK843517
Submission
- Device name
- Minuteman CO2 Microsurg Laser Dermatol-
- Applicant
- American Surgical Laser, Inc.
Mchenry, IL, US - Received
- September 5, 1984
- Decision date
- December 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEY
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| K050519 | Advanced Turbo Drive SystemGEY · Special | Linvatec Corp. | 05/17/2005SE |
| K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsGEY · Special | Arthrocare Corp. | 03/28/2002SE |
| K012738 | Symphony Graft Delivery System (GDS)GEY · Traditional | Depuyacromed | 11/14/2001SE |
| K972308 | Mednext 1000 DrillGEY · Traditional | Mednext, Inc. | 08/20/1997SE |
| K971941 | Aqua SprayGEY · Traditional | Boyd Industries, Inc. | 08/14/1997SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
More from Biomedical Ent., 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 |
| K843514 | Minuteman CO2 Microsurgical Laser OtoEWG · Traditional | 12/04/1984SE |
Questions and answers
When was Minuteman CO2 Microsurg Laser Dermatol- cleared by the FDA?
Minuteman CO2 Microsurg Laser Dermatol- (K843517) received a 510(k) decision of Substantially Equivalent on December 7, 1984, 93 days after the submission was received.
What is the product code of K843517?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.