Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000548922

FEI Number

1000548922

Entity Name

ALL QUALITY & SERVICES, INC.

City/State/Country

Fremont, CA, US

Establishment Address

47817 Fremont Blvd, Fremont, CA 94538, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

All Quality & Services, Inc. (Owner Number: 10046808)

Owner / Operator Contact Address

2010 Merritt Dr, Garland, TX 75041, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KneeAlign Femoral Drill Guide, Resection Guide Lift ware Level Veloxion Controller Ophthalmic GEMINI 810 + 980 Soft Tissue Laser Gemini 2 810+980 Soft Tissue Laser Gemini 810+980 Diode Laser Massager, Powered Inflatable Tube Pack, Hot or Cold, Water Circulating Liftware Lift Labs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-03-28
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2017-03-28
IKW	Utensil, Homemaking	Physical Medicine	Class 1	890.5050	2016-12-14
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2025-05-01
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2018-09-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2018-02-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-06-06
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2023-06-06
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-06-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-06-06
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-06-06
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-07-07
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2021-07-07
ILC	Utensil, Eating	Physical Medicine	Class 1	890.5050	2014-05-16

Official Correspondent

Amir Nosrati

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

All Quality & Services, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015907115	ALL QUALITY & SERVICES, INC.	Garland, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000548922. Last updated year: 2026. Please use registration number 1000548922 when referencing this establishment in official correspondence.