FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MILLENNIUM MICROSURGICAL SYSTEM
K Number: K022760
·
Decision Nov 18, 2002
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
88
Review Days
90
Basic Information
- Device Name
- MILLENNIUM MICROSURGICAL SYSTEM
- K Number
- K022760
- 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
- BAUSCH & LOMB, INC.
- Date Received
- August 20, 2002
- Decision Date
- November 18, 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 BAUSCH & LOMB, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | Sep 11, 2013 | Substantially Equivalent |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI | Dec 20, 2012 | Substantially Equivalent |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Sep 28, 2012 | Substantially Equivalent |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Apr 30, 2012 | Substantially Equivalent |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Jan 24, 2012 | Substantially Equivalent |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Oct 25, 2011 | Substantially Equivalent |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Aug 17, 2010 | Substantially Equivalent |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | Nov 18, 2009 | Substantially Equivalent |
| K082473 | BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM | Jan 5, 2009 | Substantially Equivalent |
| K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | Oct 16, 2008 | Substantially Equivalent |