FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION
K Number: K914827
·
Decision Mar 27, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
14
Review Days
157
Basic Information
- Device Name
- LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION
- K Number
- K914827
- 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
- LASER PHOTONICS, INC.
- Date Received
- October 22, 1991
- Decision Date
- March 27, 1992
- 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 LASER PHOTONICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K934501 | LASER PHOTONICS ML755 DERMABLASER | Aug 30, 1994 | Substantially Equivalent |
| K933140 | RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM | Mar 2, 1994 | Substantially Equivalent |
| K924537 | LPI ML210 HOLMIUM SURGICAL LASER | Apr 7, 1993 | Substantially Equivalent |
| K920334 | LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH. | Mar 31, 1993 | Substantially Equivalent |
| K915631 | LPI ML 100/532 AND ML 532 SURGICAL LASER | Jun 15, 1992 | Substantially Equivalent |
| K904841 | LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED | Apr 19, 1991 | Substantially Equivalent |
| K910233 | LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST | Apr 12, 1991 | Substantially Equivalent |
| K904354 | LPI MULILASE YAG/532 SURGICAL LASER SYSTEM | Dec 19, 1990 | Substantially Equivalent |
| K904331 | L.P.I. LASER DELIVERY SYSTEM | Dec 17, 1990 | Substantially Equivalent |
| K904229 | MULTILASE 60 | Dec 12, 1990 | Substantially Equivalent |