FDA.reportPublic FDA data

Q-Lase™ Adjustable Sheath

Primary DI
B145115150
Brand
Q-Lase™ Adjustable Sheath
Company
OPTICAL INTEGRITY INC
Model
11515
Device description
Q-Lase Adjustable Sheath
Published
2017-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered laser surgical instrument

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022338000OPTICAL INTEGRITY GENERAL SHAPED FIBEROptical Integrity, Inc.2002-10-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B145115151PackageHIBCC5In Commercial Distribution
B145115152PackageHIBCC10In Commercial Distribution
B145115150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter800Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store at room temperature
Storage Environment Temperature10 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(850)233-5512customercare@opticalintegrity.com

Regulatory Flags#

DUNS number
024050887
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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00810077631294SmartScopeSU-200-RT119202024-03-22
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00810077630983SmartScopeSU-550-RT119232024-03-22
00810077630990SmartScopeSU-1000-RT119242024-03-22

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