Apollo 9500
FDA 510(k) K974369 · Ion Laser Technology
510(k) numberK974369
Submission
- Device name
- Apollo 9500
- Applicant
- Ion Laser Technology
Salt Lake City, UT, US - Received
- November 20, 1997
- Decision date
- January 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K944317 | Genesis 2000GEX · Traditional | 10/11/1994SE |
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| K915656 | Carbon Dioxide CO2 LaserGEX · Traditional | 04/10/1992SE |
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Questions and answers
When was Apollo 9500 cleared by the FDA?
Apollo 9500 (K974369) received a 510(k) decision of Substantially Equivalent on January 6, 1998, 47 days after the submission was received.
What is the product code of K974369?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.