Next Generation Laser
FDA 510(k) K062624 · Alcon Laboratories
510(k) numberK062624
Submission
- Device name
- Next Generation Laser
- Applicant
- Alcon Laboratories
Fort Worth, TX, US - Received
- September 5, 2006
- Decision date
- November 5, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | 06/21/2024SE |
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| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
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Questions and answers
When was Next Generation Laser cleared by the FDA?
Next Generation Laser (K062624) received a 510(k) decision of Substantially Equivalent on November 5, 2007, 426 days after the submission was received.
What is the product code of K062624?
The FDA product code is HQF – Laser, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4390.