NQBClass II

Conformer, Ophthalmic, Biological Tissue

21 CFR 886.3130 / Ophthalmic

NQB is the FDA product code for Conformer, Ophthalmic, Biological Tissue, a class II device type, regulated under 21 CFR 886.3130. FDA's definition for this code reads: "The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2003-12-12, and 3 recalls.

Classification record

Product code: NQB
Device name: Conformer, Ophthalmic, Biological Tissue
FDA definition: The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
Regulation: 21 CFR 886.3130
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 3

Clearances, product code NQB

By decision year

1 clearance under product code NQB with a decision year between 2003 and 2003, 2003 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NQB by decision year
Year	Clearances
2003	1

Applicants with the most clearances

Product code NQB

Applicants holding the most 510(k) clearances under product code NQB
Applicant	Clearances
Bio-Tissue, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NQB

K032104Class IIAmniolensBio-Tissue, Inc. / cleared 2003-12-12

Recent recalls

Product code NQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)