FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
K Number: K032991
·
Decision Sep 14, 2004
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
7
Review Days
355
Basic Information
- Device Name
- LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
- K Number
- K032991
- 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
- LIGHT AGE, INC.
- Date Received
- September 25, 2003
- Decision Date
- September 14, 2004
- 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 LIGHT AGE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K113115 | EPICARE YAG | Apr 3, 2012 | Substantially Equivalent |
| K110370 | Q-CLEAR | Sep 15, 2011 | Substantially Equivalent |
| K091625 | EPICARE-DUO LASER SYSTEM | Nov 3, 2009 | Substantially Equivalent |
| K033259 | LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 | Feb 25, 2004 | Substantially Equivalent |
| K983977 | LIGHT AGE EPICARE ALEXANDRITE LASER | Jan 7, 1999 | Substantially Equivalent |
| K980131 | ALEX TA2 ERASER | Feb 17, 1998 | Substantially Equivalent |