Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
FDA 510(k) K231011 · Meridian AG
510(k) numberK231011
Submission
- Device name
- Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
- Applicant
- Meridian AG
Thun, CH - Received
- April 10, 2023
- Decision date
- September 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQF – Laser, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
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| K113390 | Laser Indirect Ophthalmoscope 500(LIO-500)GEX · Traditional | 02/14/2012SE |
| K102375 | LuciaILY · Traditional | 02/25/2011SE |
| K081962 | Lapex BCSILY · Traditional | 12/29/2008SE |
| K072823 | Merilas 532AHQF · Traditional | 12/14/2007SE |
| K034009 | Lapex 2000NHN · Abbreviated | 01/21/2005SE |
| K023238 | McpulseJOM · Traditional | 02/19/2003SE |
| K023045 | Microrupter VLXS · Traditional | 09/26/2002SE |
| K020360 | ABR-2000GZO · Traditional | 08/29/2002SE |
Questions and answers
When was Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse cleared by the FDA?
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011) received a 510(k) decision of Substantially Equivalent on September 12, 2023, 155 days after the submission was received.
What is the product code of K231011?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.