Who else makes this device?

Name: SM1
Brand: SM1

SM1 · Light, Surgical, Fiberoptic → General & Plastic Surgery

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FST
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42

Record

Regulatory record for SM1
Listed by	Medical Illumination International, Inc, United States
FDA product code	FST
Device type	Light, Surgical, Fiberoptic
Device class	Class 2
Regulation	21 CFR 878.4580
Establishment	Repacker / relabeller, Manufacturer
510(k)	K100388
Record published	2024-09-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Packaging	Box

Catalogue Numbers

Catalogue numbers for SM1
Catalogue number	Size	Status
SM1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
System TWO LED	Medical Illumination International, Inc	109
Vu	Medical Illumination International, Inc	48
Maxx Luxx LED	Avante	30
VistOR MS LED	Medical Illumination International, Inc	21
MI Product Line	Medical Illumination International, Inc	20
Vision LED	Avante	18
Fiberoptic Cable	Black & Black Surgical, Inc.	17
MaXcess	Nuvasive, Inc.	17
Integra®	Integra Lifesciences (Ireland) Limited	16
Integra®	Integra LifeSciences Production Corporation	14
Snowden-Pencer	Steris Corporation	11
Vistor PRO LED	Medical Illumination International, Inc	10

Showing 12 of 85. All products under Light, Surgical, Fiberoptic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K100388	2010-06-22
K053227	2006-01-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

SM1