Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)
FDA 510(k) K112977 · Alcon Research, Ltd.
510(k) numberK112977
Submission
- Device name
- Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- October 6, 2011
- Decision date
- March 27, 2012
- 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 III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4) cleared by the FDA?
Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4) (K112977) received a 510(k) decision of Substantially Equivalent on March 27, 2012, 173 days after the submission was received.
What is the product code of K112977?
The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.