FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS
K Number: K014040
·
Decision Jun 3, 2002
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
4
Review Days
178
Basic Information
- Device Name
- FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS
- K Number
- K014040
- 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
- ALTUS MEDICAL, INC.
- Date Received
- December 7, 2001
- Decision Date
- June 3, 2002
- 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 ALTUS MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K033768 | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE | Feb 17, 2004 | Substantially Equivalent |
| K023954 | ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES | Mar 18, 2003 | Substantially Equivalent |
| K022226 | ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS | Oct 8, 2002 | Substantially Equivalent |