FDA.reportPublic FDA data

SAFE® System Surgical Smoke Evacuator

Primary DI
00850043007067
Brand
SAFE® System Surgical Smoke Evacuator
Company
Hydrafacial LLC
Model
10000
Catalog number
10000
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K880890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880890000THE S.A.F.E. SYSTEMPfizer Laser Systems1988-05-11FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043007067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043007067008500430070678500430070670850043007067

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Contacts#

Phone, Email table
PhoneEmail
800-603-4996contact@edgeforlife.com

Regulatory Flags#

DUNS number
364134791
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007534930SKINSTYLUS STERILOCK 12-PIN CARTRIDGE IN POUCH10445104452026-08-19
00810007534947SKINSTYLUS STERILOCK 36-PIN CARTRIDGE IN POUCH10446104462026-08-19
00810007534954SKINSTYLUS STERILOCK HILO CARTRIDGE IN POUCHSL38679SL386792026-08-19
00810007533643Hydrafacial™ Syndeo™ BLACK 240V KOREA240V Black, Non Medical2026-03-27
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMSKINSTYLUS STERILOCK MICROSYSTEM2026-03-27
00850043007371Del Sol Blue Light Therapy SystemCordless (EU)70392-012017-07-03
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONAL240V Black, Non Medical70290-03-01-ITL2026-03-13
00810007534756Hydrafacial™ Lip TipHydrafacial™ Lip Tip2025-07-16
00810007534763HydraScalp™ Tip, Purify, 6-PackHydraScalp™ Tip, Purify, 6-Pack2025-07-16
00810007534770HydraScalp™ Tip, Nourish, 6-PackHydraScalp™ Tip, Nourish, 6-Pack2025-07-16
00810007532394Hydrafacial Syndeo120V, Black7000078-BLK2024-07-11
00810007531311Hydrafacial MD Elite240V70290-03-012024-07-18
00810007531540Hydrafacial MD Elite120V70143-03-012024-07-18
00810007531595Hydrafacial MD Allegro120V704152024-07-18
00810007532400Hydrafacial Syndeo240V Black7000079-BLK2024-07-18
00810007532479Hydrafacial Syndeo120V, White7000078-WHT2024-07-18
00810007532486Hydrafacial Syndeo240V White7000079-WHT2024-07-18
00810007532493Hydrafacial Syndeo240V White No-Perk7000079-WHT-NPK2024-07-18
00810007532509Hydrafacial Syndeo120V, White No Perk7000078-WHT-NPK2024-07-18
00810007532516Hydrafacial Syndeo240V Black No Perk7000079-BLK-NPK2024-07-18

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Primary DI, Brand, Company table
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