FDA applicant

Custom Optical Frames, Inc.

Rockville, MD4 decisions1993–19970 recalls

FDA records 4 decisions for Custom Optical Frames, Inc. (Rockville, MD) from 1993 to 1997: 4 510(k) clearances. Most are in product codes HQY (Sunglasses (Non-Prescription Including…) and HQZ (Frame, Spectacle). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Custom Optical Frames, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Custom Optical Frames, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Custom Optical Frames, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Custom”

FDA records each applicant name separately; these may or may not be the same firm.

Custom Pack Reliability 21 Custom Spine, Inc. 14 Custom Medical Products, Ltd. 14 Custom Services Intl., Inc. 9 Custom Orthopaedic Solutions, Inc. 8 Custom Ultrasonics 6 Custom Surgical Products, Inc. 4 Custom Medical, Inc. 3 Custom Medical Devices Intl., Inc. 3 Custom Cardio Components 2 Custom Medical Plastics, Inc. 2 Custom Hospitals Products 1

Custom Optical Frames, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Custom”