Monarch II Iol Delivery System
FDA 510(k) K003768 · Alcon Research, Ltd.
510(k) numberK003768
Submission
- Device name
- Monarch II Iol Delivery System
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- December 6, 2000
- Decision date
- January 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSS – Folders And Injectors, Intraocular Lens (Iol)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Specialty
- Ophthalmic
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Questions and answers
When was Monarch II Iol Delivery System cleared by the FDA?
Monarch II Iol Delivery System (K003768) received a 510(k) decision of Substantially Equivalent on January 5, 2001, 30 days after the submission was received.
What is the product code of K003768?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.