Bausch + Lomb: FDA 510(k) clearances across all its applicant names

FDA lists 277 510(k) clearances, 33 PMA and 0 De Novo decisions across the 8 applicant names Caduvo groups under Bausch + Lomb, first 1976, latest 2024. Median 510(k) review time across these names: 78 days. Since 2017 the median was 78 days, against 107 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 8 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 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.

Top product codes

Plus 89 more product codes.

Review panels

• Ophthalmic (246)
• General and Plastic Surgery (23)
• Radiology (8)
• Clinical Chemistry (6)
• Dental (6)
• Ear, Nose and Throat (6)
• Neurology (5)
• General Hospital (4)
• Orthopedic (2)
• Gastroenterology and Urology (1)
• Pathology (1)

Most recent Bausch + Lomb 510(k) clearances

267 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

91 product recalls in 35 recall events under these names; 3 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.

Storz Instrument Co (1986, ophthalmic surgery; unrelated to KARL STORZ), Chiron Vision (1997), Technolas Perfect Vision (2013). Includes filings made before each acquisition.

Sources

• https://en.wikipedia.org/wiki/Bausch_%2B_Lomb

Frequently asked questions

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

FDA lists 277 510(k) clearances, 33 PMA and 0 De Novo decisions across the 8 applicant names Caduvo groups under Bausch + Lomb, first 1976, latest 2024. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Bausch + Lomb file under?

The names with the most 510(k) clearances in this group are Bausch & Lomb, Inc. (102); Storz Instrument Co. (101); Chiron Vision Corp. (34); Bausch & Lomb, Incorporated (23); Technolas Perfect Vision GmbH (10). The full list of 8 names is on this page.

How long does FDA take to clear Bausch + Lomb 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 78 days. Since 2017 the median was 78 days, against 107 days for all cleared 510(k)s in the same product codes.

Does the Bausch + Lomb 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 277 Bausch + Lomb clearances with predicates and recalls
• Run predicate analysis for product code HQC, Bausch + Lomb'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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