FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMOOTHLASE ALEXANDRITE LASER SYSTEM
K Number: K990043
·
Decision Feb 11, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
36
Basic Information
- Device Name
- SMOOTHLASE ALEXANDRITE LASER SYSTEM
- K Number
- K990043
- 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
- LEISEGANG MEDICAL, INC.
- Date Received
- January 6, 1999
- Decision Date
- February 11, 1999
- 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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|---|---|---|---|
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| K912789 | LM-100/200LOW FLOW INSUFFLATOR | Sep 20, 1991 | Substantially Equivalent |
| K913135 | LM-300TWIN | Sep 18, 1991 | Substantially Equivalent |
| K911212 | LM-150HT LIGHT SOURCE | May 23, 1991 | Substantially Equivalent |
| K902313 | LM-1Z ZOOM SCOPE | Sep 4, 1990 | Substantially Equivalent |
| K854767 | LM 1000 | Jan 24, 1986 | Substantially Equivalent |