FDA.reportPublic FDA data

Stellar M22™

Primary DI
07290117772195
Brand
Stellar M22™
Company
LUMENIS BE LTD
Model
Stellar M22™ RFX
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193500000Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.2020-01-16GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117772195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117772195072901177721957290117772195

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600763501
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
07290117771037LightSheer Duet, with ET and HS HandpiecesNA2023-06-22
07290117771068LightSheer Desire LightNA2023-06-22
07290117771082LightSheer Desire, BasicNA2023-06-22
07290117771044LightSheer® Duet ET™ HandpieceNA2023-03-22
07290117771051LightSheer® Duet HS™ HandpieceNA2023-03-22
17290117772420OPT™ ShieldsNA2023-12-26
17290117771829DeepFX Disposable TipsNA2023-12-04
17290117771836DeepFX Air Disposable TipsNA2023-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008164690216981150-500LASER PERIPHERALS, LLCGEX2026-06-08
G866ELITELT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080004MTONE EVOM & T SRLONG2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONG2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONG2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONG2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONG2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
07898961835013ETHEREA-MXVYDENCE MEDICALONF2024-05-27
07898961835204ZYE YAGVYDENCE MEDICALONF2024-05-27
07898961835211ZYE ALXVYDENCE MEDICALONF2024-05-27