FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K Number: K872253
·
Decision Oct 6, 1987
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
47
Applicant Total
51
Review Days
139
Basic Information
- Device Name
- CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
- K Number
- K872253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- SURGICAL LASER TECHNOLOGIES, INC.
- Date Received
- May 20, 1987
- Decision Date
- October 6, 1987
- Product Code
- HHR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHR | Laser, Surgical, Gynecologic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHR), ordered by most recent decision date.
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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 |