FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
K Number: K882908
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
51
Review Days
80
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
- SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
- K Number
- K882908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgical Laser Technologies, Inc.
- Date Received
- July 12, 1988
- Decision Date
- September 30, 1988
- 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 Surgical Laser Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042211 | MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS | Nov 8, 2004 | Substantially Equivalent |
| K023624 | SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 | Jan 27, 2003 | Substantially Equivalent |
| K011409 | SLT LASERPRO CTH HOLMIUM LASER SYSTEM | Jun 14, 2001 | Substantially Equivalent |
| K010041 | SLT DIFFUSER FIBER | Mar 7, 2001 | Substantially Equivalent |
| K984018 | HEMOSLEEVE, MODEL 4.0MM, 5.5MM | Mar 15, 1999 | Substantially Equivalent |
| K983050 | PNEUMATIC CUTTER SYSTEM | Nov 25, 1998 | Substantially Equivalent |
| K981041 | SLT BIPOLAR SHEATH | Aug 27, 1998 | Substantially Equivalent |
| K972548 | SLT CL MD CONTACT LASER SYSTEM | Apr 21, 1998 | Substantially Equivalent |
| K980156 | SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS | Feb 27, 1998 | Substantially Equivalent |
| K960821 | SLT FUMICH PROBE GUIDE | May 16, 1996 | Substantially Equivalent |