Photcoagulator KR-568 Laser Spectrum Elite K1
FDA 510(k) K911104 · Hgm Medical Laser Systems, Inc.
510(k) numberK911104
Submission
- Device name
- Photcoagulator KR-568 Laser Spectrum Elite K1
- Applicant
- Hgm Medical Laser Systems, Inc.
Salt Lake City, UT, US - Received
- March 13, 1991
- Decision date
- June 11, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FEX – Instrument, Catheter, Punch
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K771725 | Biosp. Total Ossicular Replace. Prosthe.FEX · Traditional | Xomed, Inc. | 09/26/1977SE |
More from Xomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921300 | Model PC Argon Ion LaserGEX · Traditional | 10/06/1992SE |
| K914484 | Litespot(Tm) Laser Indirect OphthalmoscopeHLI · Traditional | 01/06/1992SE |
| K913569 | Compac a, Elite a, Elite a Plus, Surgica aGEX · Traditional | 10/17/1991SE |
| K912628 | Air Argon Ion Lasers Various ModelsGEX · Traditional | 09/13/1991SE |
| K910272 | HGM Combination Nd:Yag & Solid State GreenGEX · Traditional | 08/09/1991SE |
| K912438 | Models 5,8,20,20S Argon Ion LasersGEX · Traditional | 07/17/1991SE |
| K910602 | HGM Argon Ion & Solid Light Laser for DentistryGEX · Traditional | 06/24/1991SE |
| K910898 | Surgica(Tm) HGEX · Traditional | 05/31/1991SE |
| K904699 | Compac(Tm) Diode LasersHQF · Traditional | 04/25/1991SE |
| K904700 | Endocoagulator KRS568(TM) LaserGEX · Traditional | 02/19/1991SE |
Questions and answers
When was Photcoagulator KR-568 Laser Spectrum Elite K1 cleared by the FDA?
Photcoagulator KR-568 Laser Spectrum Elite K1 (K911104) received a 510(k) decision of Substantially Equivalent on June 11, 1991, 90 days after the submission was received.
What is the product code of K911104?
The FDA product code is FEX – Instrument, Catheter, Punch, a Class I (low risk) device regulated under 21 CFR 876.5090.