Bausch & Lomb, Incorporated: FDA filings under this applicant name

FDA lists 23 510(k) clearances under the applicant name “Bausch & Lomb, Incorporated” (first 2002, latest 2024), plus 1 PMA decision, across 8 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Since 2017 the median was 74 days, against 100 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Bausch + Lomb, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Bausch & Lomb, Incorporated took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.

Top product codes

Review panels

• Ophthalmic (24)

Most recent Bausch & Lomb, Incorporated 510(k) clearances

13 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-08-25.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Bausch & Lomb, Incorporated is the lead sponsor of 86 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:

• NCT06594185: A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction (Completed, started 2024-08-29)
• NCT06333015: Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract Extraction (Active not recruiting, started 2024-08-07)
• NCT06333028: A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction (Completed, started 2024-05-30)
• NCT06305663: A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children (Recruiting, started 2024-03-29)
• NCT06053736: 1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses (Completed, started 2023-10-04)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Bausch & Lomb, Inc. (102 510(k)s)
• Bausch & Lomb Pharmaceutical, Inc. (6 510(k)s)
• Bausch + Lomb, Incorporated (4 510(k)s)
• Bausch and Lomb (3 510(k)s)
• Bausch and Lomb, Incorporated (3 510(k)s)
• Bausch Health Americas Incorporated (1 510(k)s)
• Bausch & Lomb Healthcare and Optics Worldwide (1 510(k)s)
• Bausch Health (0 510(k)s)
• Bausch Health Companies, Inc. (0 510(k)s)
• Bausch + Lomb Ireland Limited (0 510(k)s)
• Bausch & Lomb Surgical, Inc. (0 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Bausch & Lomb, Incorporated?

FDA lists 23 510(k) clearances under the applicant name “Bausch & Lomb, Incorporated” (first 2002, latest 2024), plus 1 PMA decision, across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Bausch & Lomb, Incorporated?

The median time from FDA receipt to decision across 510(k)s cleared under the name Bausch & Lomb, Incorporated is 89 days. Since 2017: 74 days, versus 100 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Bausch & Lomb, Incorporated?

The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 7); LPN (Accessories, Soft Lens Products, 5); HQD (Lens, Contact (Other Material) - Daily, 4).

Next steps

• See all 23 Bausch & Lomb, Incorporated clearances with predicates and recalls
• Run predicate analysis for product code LPL, Bausch & Lomb, Incorporated's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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