Model 10-C with an SA-10A/U Opt. Attach. Hemorrho.
FDA 510(k) K871030 · Directed Energy, Inc.
510(k) numberK871030
Submission
- Device name
- Model 10-C with an SA-10A/U Opt. Attach. Hemorrho.
- Applicant
- Directed Energy, Inc.
Los Angeles, CA, US - Received
- March 16, 1987
- Decision date
- May 15, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LNK – Laser For Gastro-Urology Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | Teknomed, Inc. | 05/21/1993SE |
| K901723 | MDL-2000 LasertripterLNK · Traditional | Candela Laser Corp. | 07/13/1990SE |
| K874255 | Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K874253 | Nd:Yag Surgical Laser for Gastro/Urology Applica.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K880256 | Model 4060 N Nd:Yag Laser for Gastroenterology UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K880193 | Model 4060 N Nd:Yag Laser for Urological UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K875039 | Nd:Yag 100 Surgical Laser for Gastro. and UrologyLNK · Traditional | Surgilase, Inc. | 04/13/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | Cooper Lasersonics, Inc. | 04/11/1988SE |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
More from Lasermatic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K904930 | Surgical Carbon Dioxide Laser Syst Model 20-CHGEX · Traditional | 03/21/1991SE |
| K894241 | Model 20-CH W/ AR-10A/U Optical AttachmentGEX · Traditional | 06/18/1990SE |
| K883738 | Carbon Dioxide Laser System Model 20-CX W/Attach.GEX · Traditional | 11/15/1988SE |
| K882926 | Model AU-1 Accessory UnitGEX · Traditional | 09/09/1988SE |
| K880216 | Model 20C W/An AR-10A/U & RL-20A/U for Arthroscop.GEX · Traditional | 03/04/1988SE |
| K873331 | Ortho. Gas Insufflator Model IN-2 for Arthro. SurgHRX · Traditional | 02/17/1988SE |
| K872709 | Model 20-C, RL-20A/U, OB-10A/UHHR · Traditional | 02/02/1988SE |
| K870841 | Model 20-C W/BR-20A/U Attach/Model HL-3.0 OB/GYNHHR · Traditional | 02/02/1988SE |
| K872711 | Model 20-C W/AR-10A/U Attach. for Arthro. SurgeryGEX · Traditional | 09/28/1987SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | 09/24/1987SE |
Questions and answers
When was Model 10-C with an SA-10A/U Opt. Attach. Hemorrho. cleared by the FDA?
Model 10-C with an SA-10A/U Opt. Attach. Hemorrho. (K871030) received a 510(k) decision of Substantially Equivalent on May 15, 1987, 60 days after the submission was received.
What is the product code of K871030?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.