FDA.reportPublic FDA data

DB-550SF

Primary DI
00816469020905
Brand
DB-550SF
Company
LASER PERIPHERALS, LLC
Model
DB-550SF
Catalog number
DB-550SF
Device description
ScatterFree™ 550u Lateral Emitting Laser Fiber
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816469020905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816469020905008164690209058164690209050816469020905

GMDN Terms#

Term, Definition table
TermDefinition
Urogenital surgical laser system beam guide, single-useA sterile, flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, and ureteral conditions (e.g., tumours, condylomas); it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177234754
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00816469021674LG-200-CNLG-200-CNLG-200-CN2024-12-06
00816469021681LG-200-CN-PLLG-200-CN-PLLG-200-CN-PL2024-12-06
00816469021650LG-T200LG-T200LG-T2002024-07-15
00816469021667LG-T200-PLLG-T200-PLLG-T200-PL2024-07-15
00816469021629DBSS-272DBSS-272DBSS-2722022-05-22
00816469021636DBSS-272-PLDBSS-272-PLDBSS-272-PL2022-05-22
00816469021612DB-600R-5DB-600R-5DB-600R-52021-11-19
00816469021599HTB-800HTB-800HTB-8002021-03-22
00816469021605HTB-800-PLHTB-800-PLHTB-800-PL2021-03-22
00816469021582DB-600R-HPT-PLDB-600R-HPT-PLDB-600R-HPT-PL2020-09-21
00816469021537LG-272-N-PL-MLG-272-N-PL-MLG-272-N-PL-M2020-08-10
00816469021544LG-365-E-PL-MLG-365-E-PL-MLG-365-E-PL-M2020-08-10
00816469021551LG-550-E-PL-MLG-550-E-PL-MLG-550-E-PL-M2020-08-10
00816469021568RTB-272-PL-MRTB-272-PL-MRTB-272-PL-M2020-08-10
00816469021575RB-365-PL-MRB-365-PL-MRB-365-PL-M2020-08-10
00816469021520LG-272-N-PLLG-272-N-PLLG-272-N-PL2020-01-10
00816469021414FC-001FC-001FC-0012019-12-02
00816469021421FC-002 ACFC-002 ACFC-002 AC2019-12-02
00816469021438FS-272FS-272FS-2722019-12-02
00816469021445FS-365FS-365FS-3652019-12-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08052286590517LASER THERMAL THERAPY KIT L EELESTA SPAGEX2026-03-24
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06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
02816901023318NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
01816901024156NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
00860015460615NextGen Aesthetics CO2T AESTHETICS LLCGEX2026-03-12
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08034108512877TORODEKA M.E.L.A. SRLGEX2026-03-11
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