FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER PHOTONICS ML755 DERMABLASER
K Number: K934501
·
Decision Aug 30, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
14
Review Days
350
Basic Information
- Device Name
- LASER PHOTONICS ML755 DERMABLASER
- K Number
- K934501
- 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
- September 14, 1993
- Decision Date
- August 30, 1994
- 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 | ||
|---|---|---|---|
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| K915631 | LPI ML 100/532 AND ML 532 SURGICAL LASER | Jun 15, 1992 | Substantially Equivalent |
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| 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 |