FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUXSCOPE
K Number: K973193
·
Decision Nov 21, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
176
Applicant Total
15
Review Days
88
Basic Information
- Device Name
- LUXSCOPE
- K Number
- K973193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LUXTEC CORP.
- Date Received
- August 25, 1997
- Decision Date
- November 21, 1997
- 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 LUXTEC CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K970642 | TENOSCOPE | May 21, 1997 | Substantially Equivalent |
| K970562 | TENOSNARE | May 14, 1997 | Substantially Equivalent |
| K950960 | REDDY ILLUMINATOR | Sep 8, 1995 | Substantially Equivalent |
| K895248 | IMS5000 ILLUMINATED LOUPES | Sep 15, 1989 | Substantially Equivalent |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | Apr 26, 1989 | Substantially Equivalent |
| K864387 | LUXTEC FIBEROPTIC CABLES | May 22, 1987 | Substantially Equivalent |
| K864383 | LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS | Jan 14, 1987 | Substantially Equivalent |
| K864382 | FRAZIER SUCTION TUBE | Jan 14, 1987 | Substantially Equivalent |
| K864385 | LUXTEC LIGHT SOURCES | Jan 13, 1987 | Substantially Equivalent |
| K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC | Jan 9, 1987 | Substantially Equivalent |