FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXT GENERATION LASER
K Number: K062624
·
Decision Nov 5, 2007
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
47
Review Days
426
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEXT GENERATION LASER
- K Number
- K062624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Laboratories
- Date Received
- September 5, 2006
- Decision Date
- November 5, 2007
- Product Code
- HQF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQF), ordered by most recent decision date.
Voyager DSLT (430840610)
FDA 510(k)
FDA Class 2
·Ophthalmic
INTEGRE LIO
FDA 510(k)
FDA Class 2
·Ophthalmic
Navilas Laser System 577sl (156691)
FDA 510(k)
FDA Class 2
·Ophthalmic
EyeQ nanoECP
FDA 510(k)
FDA Class 2
·Ophthalmic
Leos Laser and Endoscopy System
FDA 510(k)
FDA Class 2
·Ophthalmic
LYNX Photocoagulator
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Alcon Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K062865 | SMALL VOLUME SYRINGE | Aug 23, 2007 | Substantially Equivalent |
| K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 | Apr 11, 2000 | Substantially Equivalent |
| K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | Sep 16, 1999 | Substantially Equivalent |
| K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | May 10, 1999 | Substantially Equivalent |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Jan 14, 1999 | Substantially Equivalent |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Dec 18, 1998 | Substantially Equivalent |
| K981561 | LIQUID ENZYME ID 90133 | Jul 24, 1998 | Substantially Equivalent |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Jul 9, 1998 | Substantially Equivalent |
| K981103 | TURBOSONICS LIMITED REUSE ULTRASONIC TIP | Jun 23, 1998 | Substantially Equivalent |