FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANNING LASERLINK
K Number: K130195
·
Decision Nov 1, 2013
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
43
Review Days
277
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
- SCANNING LASERLINK
- K Number
- K130195
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumenis, Inc.
- Date Received
- January 28, 2013
- Decision Date
- November 1, 2013
- 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 Lumenis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211979 | Lumenis Y&R Laser System | Jun 21, 2022 | Substantially Equivalent |
| K151109 | Lumenis Smart532 Laser System | Oct 30, 2015 | Substantially Equivalent |
| K111213 | VISION ONE LASER SYSTEM | Jul 25, 2011 | Substantially Equivalent |
| K100228 | VERSAPULSE MODEL P20 LASER SYSTEM | Feb 24, 2010 | Substantially Equivalent |
| K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | Sep 30, 2009 | Substantially Equivalent |
| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | Dec 18, 2008 | Substantially Equivalent |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Sep 11, 2008 | Substantially Equivalent |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | Apr 7, 2006 | Substantially Equivalent |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | Mar 9, 2006 | Substantially Equivalent |
| K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES | Nov 15, 2005 | Substantially Equivalent |