FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUORESCENCE ILLUMINATOR ACCESSORY
K Number: K770652
·
Decision Jul 6, 1977
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
0
Applicant Total
92
Review Days
91
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Basic Information
- Device Name
- FLUORESCENCE ILLUMINATOR ACCESSORY
- K Number
- K770652
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- April 6, 1977
- Decision Date
- July 6, 1977
- Product Code
- IBK
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| IBK | Microscope, Fluorescence/U.V. | FDA class 1 | Pathology |
Other Clearances by Bausch & Lomb, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K173480 | Crystalsert Lens Delivery System | Dec 11, 2017 | Substantially Equivalent |
| K151102 | Bausch + Lomb Injector System | May 22, 2015 | Substantially Equivalent |
| 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 |