FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLT CONTACT LASER SYSTEM OCULOPLASTICS
K Number: K881134
·
Decision Jun 6, 1988
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
176
Applicant Total
51
Review Days
82
Basic Information
- Device Name
- SLT CONTACT LASER SYSTEM OCULOPLASTICS
- K Number
- K881134
- 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
- March 16, 1988
- Decision Date
- June 6, 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 |
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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 |