FDA.report

OptiSet™

Primary DI
07290117770955
Brand
OptiSet™
Company
LUMENIS BE LTD
Model
OptiSet™
Device description
17290117770952 - OptiSet™ Master Pack
Published
2022-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications

CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17290117770952PackageGS124In Commercial Distribution
07290117770955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1729011777095217290117770952
07290117770955072901177709557290117770955

GMDN Terms

TermDefinition
Radiation/mechanical corneal shield, single-useA protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
600763501
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
07290117772737Multi-Spot™ Nd:YAG HeadNA2025-12-21
07290117772744M22™ Q-Switched HeadNA2025-12-21
07290117772751Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kitNA2025-12-21
07290117772768Stellar M22™ Q-Switched Nd:YAG Upgrade KitNA2025-12-21
07290117772645Black Stellar XPL HPNA2025-09-08
07290117772652Stellar XPL Module KitNA2025-09-08
07290117772447FoLiCool™ TipNA2024-03-17
07290117772522FoLix™NA2024-03-17
07290117772539FoLix™ HandpieceNA2024-03-17
07290117772393LUSTER SystemNA2024-01-22
07290117772409LUSTER HandpieceNA2024-01-22
07290117772416LUSTER Tip, RoundNA2024-01-22
17290117772420OPT™ ShieldsNA2023-12-26
07290117771372AcuPulseNA2023-12-04
07290117771389AcPulse WNA2023-12-04
07290117771396SurgiTouch™ Scanning Handpiece SetNA2023-12-04
07290117771402SurgiTouch™ Scanning Handpiece 125mmNA2023-12-04
07290117771419SurgiTouch™ Scanning Handpiece 260mmNA2023-12-04
07290117771426SurgiTouch™ Scanning Handpiece 200mmNA2023-12-04
07290117771433AcuPulse Incisional Handpiece 125 mmNA2023-12-04

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06973541158100REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
06973541158117 REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
00620974004288BetterShieldSouthmedic IncorporatedHOY2025-12-19
00757770455409Bausch + LombBausch & Lomb IncorporatedHOY2025-08-22
00883205038227Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00883205038234Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
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