Alcon: FDA 510(k) clearances across all its applicant names

FDA lists 194 510(k) clearances, 53 PMA and 0 De Novo decisions across the 15 applicant names Caduvo groups under Alcon, first 1976, latest 2026. Median 510(k) review time across these names: 83 days. Since 2017 the median was 46 days, against 108 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 15 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names took a median 46 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.

Top product codes

Plus 48 more product codes.

Review panels

• Ophthalmic (217)
• General and Plastic Surgery (24)
• Ear, Nose and Throat (2)
• General Hospital (2)
• Gastroenterology and Urology (1)

Most recent Alcon 510(k) clearances

184 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

160 product recalls in 82 recall events under these names; 69 initiated in the last five years.

Recalling firms are matched to the applicant names above by name only, so recalls filed under other names are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

CIBA Vision merged into Alcon (2011), WaveLight (2007), LenSx (2010), Transcend (2016), Ivantis (2022). Includes filings made before each acquisition.

Sources

• https://en.wikipedia.org/wiki/Alcon
• https://en.wikipedia.org/wiki/CIBA_Vision

Frequently asked questions

How many FDA 510(k) clearances are listed across Alcon's applicant names?

FDA lists 194 510(k) clearances, 53 PMA and 0 De Novo decisions across the 15 applicant names Caduvo groups under Alcon, first 1976, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Alcon file under?

The names with the most 510(k) clearances in this group are Alcon Laboratories (90); Ciba Vision Corporation (44); Alcon Research, Ltd. (17); Wavelight Laser Technologie AG (8); Alcon Manufacturing, Ltd. (6). The full list of 15 names is on this page.

How long does FDA take to clear Alcon 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 83 days. Since 2017 the median was 46 days, against 108 days for all cleared 510(k)s in the same product codes.

Does the Alcon count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 194 Alcon clearances with predicates and recalls
• Run predicate analysis for product code LPL, Alcon's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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