Light Coagulator LC 250
FDA 510(k) K881334 · Nk-Optik GmbH
510(k) numberK881334
Submission
- Device name
- Light Coagulator LC 250
- Applicant
- Nk-Optik GmbH
Munich D8000, DE - Received
- March 30, 1988
- Decision date
- November 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HAM – Apparatus, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153472 | Quiver Laparoscopic ExtendableHAM · Traditional | Itl Corporation Pty, Ltd. | 06/23/2016SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | Nikomed U.S.A., Inc. | 02/04/2000SE |
| K993306 | Nikopad Electrosurgical Grounding Pad (*Or Sold Under Commercial Names), Model 4760…HAM · Special | Paladin Medical, Inc. | 11/03/1999SE |
| K945861 | Bergen 710 EsuHAM · Traditional | Bergen Mfg. | 03/01/1995SE |
| K913300 | Laparostat(Tm)HAM · Traditional | Cook Ob/Gyn | 04/02/1992SE |
| K920100 | Gsu Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 02/03/1992SE |
| K911353 | Emc Model No. Statome 900HAM · Traditional | Emc Industries | 06/24/1991SE |
| K901248 | Abc Handpiece AdapterHAM · Traditional | Beacon Laboratories, Inc. | 04/03/1990SE |
| K895337 | Electrosurgical Coagulation Suction TubeHAM · Traditional | New England Surgical Instrument Corp. | 09/15/1989SE |
| K894762 | B100 Disposable HandpieceHAM · Traditional | Beacon Laboratories, Inc. | 09/15/1989SE |
Questions and answers
When was Light Coagulator LC 250 cleared by the FDA?
Light Coagulator LC 250 (K881334) received a 510(k) decision of Substantially Equivalent on November 16, 1989, 596 days after the submission was received.
What is the product code of K881334?
The FDA product code is HAM – Apparatus, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.