Bausch & Lomb, Inc.: FDA filings under this applicant name

FDA lists 137 510(k) clearances under 8 spellings of the applicant name “Bausch & Lomb, Inc.” (first 1977, latest 2026), plus 32 PMA decisions, across 45 product codes in 7 review panels. Median 510(k) review time under this name: 75 days. Since 2017 the median was 92 days, against 97 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, Inc. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.

Top product codes

Plus 35 more product codes.

Review panels

• Ophthalmic (152)
• Clinical Chemistry (6)
• Ear, Nose and Throat (4)
• Dental (3)
• General Hospital (1)
• Pathology (1)
• General and Plastic Surgery (1)

Most recent Bausch & Lomb, Inc. 510(k) clearances

127 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

82 product recalls in 28 recall events; 0 initiated in the last five years. Most recent: 2018-08-08.

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, Inc. 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)

SEC filings

Bausch & Lomb Corp (BLCO): EDGAR filings, CIK 1860742. An SEC registrant with the same name, matched by name only.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Bausch & Lomb, Inc. (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via MRH)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MRH)

FDA spellings included

FDA records this applicant under 8 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Bausch & Lomb, Inc. (114)
• Bausch & Lomb, Incorporated (24)
• Bausch & Lomb (18)
• Bausch + Lomb, Incorporated (4)
• Bausch and Lomb, Incorporated (3)
• Bausch and Lomb (2)
• Bausch and Lomb, Inc., (2)
• Bausch+Lomb (2)

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

Frequently asked questions

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

FDA lists 137 510(k) clearances under 8 spellings of the applicant name “Bausch & Lomb, Inc.” (first 1977, latest 2026), plus 32 PMA decisions, across 45 product codes in 7 review panels. 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, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Bausch & Lomb, Inc. is 75 days. Since 2017: 92 days, versus 97 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Bausch & Lomb, Inc.?

The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 20); LPN (Accessories, Soft Lens Products, 20); HQL (Intraocular Lens, 16).

Next steps

• See all 137 Bausch & Lomb, Inc. clearances with predicates and recalls
• Run predicate analysis for product code LPL, Bausch & Lomb, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); 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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