Data / Medical devices / United States / Bausch & Lomb Incorporated

Bausch & Lomb Incorporated: FDA-registered device maker in Wilmington, MA, United States, 15 510(k) clearances and 5 PMA approvals

Name: Bausch & Lomb Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bausch & Lomb Incorporated is registered with the FDA (registration 1281950) in Wilmington, MA, United States. It lists 7 device types. The FDA files 15 510(k) clearances and 5 PMA approvals under its listings, the newest dated February 12, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1281950
Address: 100 Research Drive, Wilmington, MA, United States, 01887
Owner or operator: Bausch & Lomb Incorporated (9913003)
Roles: Manufacturer, Specification developer
First device listed: August 1, 2005
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Intraocular Lens	HQL	3	Manufacturer	accessdata.fda.gov
Lens, Contact (Orthokeratology)	MUW	2	Manufacturer, Specification developer	accessdata.fda.gov
Lens, Contact (Other Material) - Daily	HQD	2	Manufacturer, Specification developer	accessdata.fda.gov
Lens, Contact (Polymethylmethacrylate)	HPX	U	Manufacturer, Specification developer	accessdata.fda.gov
Lens, Contact (Rigid Gas Permeable), Extended Wear	MWL	3	Manufacturer, Specification developer	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	Manufacturer, Specification developer	accessdata.fda.gov
Lens, Intraocular, Toric Optics	MJP	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 12, 2019	K183167	Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens	HQD	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
July 17, 2017	K171404	BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)	HQD	Substantially Equivalent	Bausch + Lomb, Incorporated	accessdata.fda.gov
August 15, 2007	K071266	BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
August 2, 2007	K071043	BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES	HQD	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
January 30, 2006	K053124	BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES	HQD	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
August 22, 2002	K022128	BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
April 3, 2002	K013762	RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
September 12, 2001	K011945	RIGID GAS PERMEABLE CONTACT LENS SOLUTION	HQD	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov
February 16, 2001	K003932	BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY	HQD	Substantially Equivalent	Polymer Technology	accessdata.fda.gov
October 31, 2000	K002025	RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Polymer Technology	accessdata.fda.gov
August 28, 2000	K001960	RIGID GAS PERMEABLE CONTACT LENS	HQD	Substantially Equivalent	Polymer Technology	accessdata.fda.gov
May 11, 1998	K980741	BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)	HQD	Substantially Equivalent	Polymer Technology Div. Wilmington Partners, L.P.	accessdata.fda.gov
May 6, 1997	K970698	BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS	HQD	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov
August 25, 1994	K943177	BOSTON(R) 7 - 30(ENFLUFOCON A)	HQD	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov
June 23, 1994	K942365	BOSTON VII	HQD	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 5, 2008	P060022	AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT	HQL	35	September 3, 2026	accessdata.fda.gov
June 7, 2004	P010062	EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR	NUU	14	December 16, 2025	accessdata.fda.gov
January 17, 1992	P910056	SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	58	October 23, 2026	accessdata.fda.gov
November 30, 1987	P860022	BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS	MWL	57	December 16, 2025	accessdata.fda.gov
December 23, 1983	P820065	BOSTON LENS(R) LENS - CLEAR	HPX	70	February 16, 1994	accessdata.fda.gov

Compare with other makers

Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.