FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE
K Number: K873571
·
Decision Nov 6, 1987
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
5
Review Days
65
Basic Information
- Device Name
- LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE
- K Number
- K873571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- LASERGUIDE
- Date Received
- September 2, 1987
- Decision Date
- November 6, 1987
- 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 LASERGUIDE
| K Number | Device Name | ||
|---|---|---|---|
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Mar 22, 1988 | Substantially Equivalent |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Feb 2, 1988 | Substantially Equivalent |
| K875104 | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE | Feb 2, 1988 | Substantially Equivalent |
| K873664 | LIGHT-SPOT FIBEROPTIC LASER HANDPIECE | Nov 6, 1987 | Substantially Equivalent |