Model 10-C W/FL-10A/U Optical Attachment/Opthalmic
FDA 510(k) K870839 · Directed Energy, Inc.
510(k) numberK870839
Submission
- Device name
- Model 10-C W/FL-10A/U Optical Attachment/Opthalmic
- Applicant
- Directed Energy, Inc.
Los Angeles, CA, US - Received
- February 25, 1987
- Decision date
- May 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
Other 510(k)s with product code HQF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252979 | Voyager DSLT (430840610)HQF · Traditional | Belkin Vision, Ltd. | 04/07/2026SE |
| K251507 | Integre LioHQF · Traditional | Quantel Medical | 02/06/2026SE |
| K251772 | Navilas Laser System 577sl (156691)HQF · Traditional | Od-Os GmbH | 10/29/2025SE |
| K243014 | EyeQ nanoECPHQF · Traditional | Eyeq, Inc. | 06/18/2025SE |
| K240615 | Leos Laser and Endoscopy SystemHQF · Traditional | Beaver-Visitec International, Inc. | 04/03/2025SE |
| K242397 | LYNX PhotocoagulatorHQF · Traditional | Norlase Aps | 10/25/2024SE |
| K233911 | VISULAS combiHQF · Traditional | Carl Zeiss Meditec, AG | 09/06/2024SE |
| K232417 | MR Q; MR Q Supine; MR Q SLTHQF · Traditional | Meridian AG | 01/25/2024SE |
| K230722 | Eagle deviceHQF · Traditional | Belkin Vision, Ltd. | 12/08/2023SE |
| K232051 | VISULAS greenHQF · Traditional | Carl Zeiss Meditec | 10/24/2023SE |
More from Carl Zeiss Meditec
| 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 W/FL-10A/U Optical Attachment/Opthalmic cleared by the FDA?
Model 10-C W/FL-10A/U Optical Attachment/Opthalmic (K870839) received a 510(k) decision of Substantially Equivalent on May 22, 1987, 86 days after the submission was received.
What is the product code of K870839?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.