FDA.reportPublic FDA data

Stellaris

Primary DI
00757770520251
Brand
Stellaris
Company
Bausch & Lomb Incorporated
Model
BL14304
Catalog number
BL14304
Device description
Stellaris PC with Laser with Version 4+ Software
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQEInstrument, Vitreous Aspiration And Cutting, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770520251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770520251007577705202517577705202510757770520251

GMDN Terms#

Term, Definition table
TermDefinition
Phacoemulsification/vitrectomy systemAn assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251954900014Phaco Handpiece Sophi ECOThis AGHQE2026-02-11
10380650003291UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003307UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003314UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003611UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003628UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003635UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003666UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003673UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003680UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003772UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003789UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003796UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003802UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003840UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650003857UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650004298UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004776UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004806UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004868UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650004875UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005162UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005179UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005186UNITYAlcon Laboratories, Inc.HQE2025-04-08
20380650005193UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007923UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650007947UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008050UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008067UNITYAlcon Laboratories, Inc.HQE2025-04-08
10380650008074UNITYAlcon Laboratories, Inc.HQE2025-04-08