FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTILINK(TM) LPM (LASER POWER MODULATOR)
K Number: K924166
·
Decision Feb 5, 1993
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
26
Review Days
170
Basic Information
- Device Name
- OPTILINK(TM) LPM (LASER POWER MODULATOR)
- K Number
- K924166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- XINTEC CORPORATION
- Date Received
- August 19, 1992
- Decision Date
- February 5, 1993
- 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 XINTEC CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K082230 | VECTRA PLUS LASER SYSTEM AND ACCESSORIES | Feb 3, 2010 | Substantially Equivalent |
| K990914 | POLARIS DIODE LASER SYSTEM AND ACCESSORIES | Jul 30, 1999 | Substantially Equivalent |
| K981627 | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) | Jul 31, 1998 | Substantially Equivalent |
| K981350 | ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES | Jul 9, 1998 | Substantially Equivalent |
| K971912 | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES | Nov 3, 1997 | Substantially Equivalent |
| K971065 | DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES | Jun 17, 1997 | Substantially Equivalent |
| K951935 | PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Mar 25, 1996 | Substantially Equivalent |
| K951876 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES | Mar 25, 1996 | Substantially Equivalent |
| K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Dec 27, 1995 | Substantially Equivalent |
| K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | Nov 29, 1995 | Substantially Equivalent |