Laser and Emphasis Sclerostomy Tip
FDA 510(k) K926470 · Summit Technology, Inc.
510(k) numberK926470
Submission
- Device name
- Laser and Emphasis Sclerostomy Tip
- Applicant
- Summit Technology, Inc.
Waltham, MA, US - Received
- December 28, 1992
- Decision date
- July 22, 1993
- 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
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 |
|---|---|---|
| K980675 | Summit Krumeich-Barraquer MicrokeratomeHNO · Traditional | 12/22/1998SE |
| K915651 | Omnimed Holmium Laser and Delivery SystemGEX · Traditional | 06/15/1992SE |
| K912522 | Omniview(Tm) Ophthalmic Fiberendo W/NeedleholderEQH · Traditional | 07/25/1991SE |
| K904470 | Summit Tech 19/20 Gauge Ophthalmic FiberendoscopeEQH · Traditional | 12/24/1990SE |
Questions and answers
When was Laser and Emphasis Sclerostomy Tip cleared by the FDA?
Laser and Emphasis Sclerostomy Tip (K926470) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 206 days after the submission was received.
What is the product code of K926470?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.