FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOTODERM PL.
K Number: K960772
·
Decision Sep 11, 1996
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
198
Basic Information
- Device Name
- PHOTODERM PL.
- K Number
- K960772
- 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
- ESC MEDICAL SYSTEMS LTD.
- Date Received
- February 26, 1996
- Decision Date
- September 11, 1996
- 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 ESC MEDICAL SYSTEMS LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K994014 | ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT | Feb 24, 2000 | Substantially Equivalent |
| K991935 | EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM | Jan 27, 2000 | Substantially Equivalent |
| K982119 | DIODE LASER | Feb 4, 1999 | Substantially Equivalent |
| K974536 | PHOTODERM HR SYSTEM | May 20, 1998 | Substantially Equivalent |
| K980537 | ND: YAG ACCESSORY FOR PHOTODERM SYSTEM | Apr 15, 1998 | Substantially Equivalent |
| K972872 | DERMA K LASER SYSTEM | Oct 28, 1997 | Substantially Equivalent |
| K972028 | DERMASCAN SURGICAL LASER SCANNER | Oct 24, 1997 | Substantially Equivalent |
| K963249 | EPILIGHT HAIR REMOVAL SYSTEM | Jul 7, 1997 | Substantially Equivalent |
| K964253 | DERMA 20 LASER SYSTEM | Apr 11, 1997 | Substantially Equivalent |