FDA.reportPublic FDA data

ADVANCED SURGICAL LAMP

Primary DI
B510SL700700LED1
Brand
ADVANCED SURGICAL LAMP
Company
ADVANCED INSTRUMENTATIONS, INC.
Model
SL700/700 LED
Published
2026-03-24
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B510SL700700LED1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Operating room light systemAn assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608736880
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM DUS-60002026-03-24
B510D100ADVANCED MONITOR DEFIBRILLATORD100+2026-01-14
B510PT3000ADVANCED PHOTOTHERAPY LAMP PT-30002025-08-21
B510PM200MPRO1ADVANCED PATIENT MONITORPM-200M PRO2025-07-23
B510V1000ADVANCED VENTILATORV-10002025-02-10
B510A31860ADVANCED NEONATAL INCUBATORA31862025-02-07
B510A31861ADVANCED NEONATAL INCUBATORA3186+2025-02-07
B510A4051ADVANCED INFANT WARMERA40512025-02-07
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAAM-6000+2025-02-07
B510FM9000ADVANCED FETAL MONITORFM-90002025-02-07
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPPT-20002025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPPT-50002025-02-07
B510A3158ADVANCED TRANSPORT INCUBATORA31582025-02-04
B510IP200ADVANCED INFUSION PUMPIP-2002025-02-04
B510PMMAX13ADVANCED PATIENT MONITORPM-Max132024-12-19
B510PMMAX15ADVANCED PATIENT MONITORPM-Max152024-12-19
B510PM2000A1ADVANCED PATIENT MONITORPM-2000A2020-04-16
B510PM2000APRO1ADVANCED PATIENT MONITORPM-2000A PRO2020-04-16
B510PM2000M1ADVANCED PATIENT MONITORPM-2000M2020-04-16
B510PM2000XL1ADVANCED PATIENT MONITORPM-2000XL2020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00684706009842iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009835iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-06
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
00684706009804iCE Surgical LightAmico Clinical Solutions CorpFSY2025-10-09
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
00684706007442iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00724995199364HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199388HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199395HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199401HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199425HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199432HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONFSY2021-04-09