FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS
K Number: K944091
·
Decision Oct 7, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
12
Review Days
46
Basic Information
- Device Name
- THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS
- K Number
- K944091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LCA, INC.
- Date Received
- August 22, 1994
- Decision Date
- October 7, 1994
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by LCA, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K952792 | PADLESS ELECTROSURGICAL PENCIL | Aug 28, 1995 | Substantially Equivalent |
| K935439 | SNJ SMOKE EVACUATION SUCTION WAND | Mar 7, 1994 | Substantially Equivalent |
| K935258 | HYBRID SURGICAL DEVICE MODIFICATION | Jan 13, 1994 | Substantially Equivalent |
| K925726 | ALLOY SCALPEL HANDPIECES, MODIFICATION | Nov 22, 1993 | Substantially Equivalent |
| K931070 | CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM | Oct 5, 1993 | Substantially Equivalent |
| K924160 | HYBRID SURGICAL DEVICE | Apr 23, 1993 | Substantially Equivalent |
| K923991 | ZOE LASER, CONTACT ND:YAG LASER SYSTEM | Mar 31, 1993 | Substantially Equivalent |
| K924120 | MOLDED FIBER CAP DELIVERY SYSTEM | Mar 19, 1993 | Substantially Equivalent |
| K901365 | LASER FORCEPS HANDPIECE | Aug 21, 1990 | Substantially Equivalent |
| K902562 | REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER | Jun 20, 1990 | Substantially Equivalent |