Ameri. Medical Optics Argon Laser Photo
FDA 510(k) K842251 · American Medical Optics
510(k) numberK842251
Submission
- Device name
- Ameri. Medical Optics Argon Laser Photo
- Applicant
- American Medical Optics
Walker, MI, US - Received
- May 30, 1984
- Decision date
- August 15, 1984
- 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 |
|---|---|---|
| K860001 | Barraquer-Krumeich Refractive SetHNO · Traditional | 02/04/1986SE |
| K851264 | Amer. Medical Optics Monocular Indirect OphthalmasHLI · Traditional | 05/01/1985SE |
| K851263 | Amer. Medical Optic Monocular Direct OphthalmascopHLI · Traditional | 05/01/1985SE |
| K851262 | Amer. Medical Optical Binocular Indirect OphthalmaHLI · Traditional | 04/30/1985SE |
| K844150 | Medical Optics Phacoemulsification KitHQC · Traditional | 12/11/1984SE |
| K843966 | Argon/Krypton Laser Photocoagulator SysHQB · Traditional | 11/08/1984SE |
| K843965 | Argon Laser Photocoagulator SysHQF · Traditional | 11/06/1984SE |
| K842504 | Amer. Medical Optics Digital Kerato-HQL · Traditional | 10/01/1984SE |
| K842197 | American Medical Optics I/A Kit- IrrigHQE · Traditional | 10/01/1984SE |
| K842127 | American Medical Optics Imaging SysIYO · Traditional | 09/07/1984SE |
Questions and answers
When was Ameri. Medical Optics Argon Laser Photo cleared by the FDA?
Ameri. Medical Optics Argon Laser Photo (K842251) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 77 days after the submission was received.
What is the product code of K842251?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.