Facility

Omni-Guide Holdings, Inc.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005350457
Establishment type	Manufacture Medical Device
Location	43 Manning Road Billerica, MA, US 01821
Registration status	Active · expires 2026
Parent company	OMNIGUIDE, INC. (owner-operator 9070939)
Brand names	Fiber Enabled Laser System; Intelliguide Laser System; FELS-25A; C-Las FELS-25A-LS

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IITerminated2012-11-05
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient

FDA inspections (3)

VAI2022-08-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2017-05-02
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
NAI2017-01-05
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Omni-Guide Holdings, Inc. (FEI 3005350457) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005350457-omni-guide-holdings-inc/

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