Manufacturer

CeramOptec

Germany, LatviaLegal entities : Ceram Optec SIA, CeramOptec GmbH

Markets : Austria · Belgium · Bulgaria · Croatia · Czechia · Estonia · France · Germany · Greece · Hungary · Italy · Latvia · Lithuania · Netherlands · Northern Ireland · Poland · Slovakia · Spain · Sweden · Türkiye and 1 more countries

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 32 · class II · latest in 2025 · see on the FDA website

Public contracts won : France 6

Website infolv@ceramoptec.com

7 categories, 62 models including 62 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Laser surgery instruments - consumables	Z12011085	Auriga Fiber Bare Fiber3 refs Bare Fiber, single-use, sterile3 refs Cylindrical Diffuser3 refs ELVeS®3 refs 27 others ELVeS® Kit3 refs Endoprobe ENT-24-SMA-G93/42 Endoprobe EP-20-LM-LT93/42 Endoprobe EP-20-LM-LT-CB93/42 Endoprobe EP-20-LT93/42 Endoprobe EP-20-LT-CB93/42 Endoprobe EP-23-LM-LT93/42 Endoprobe EP-23-LT93/42 Endoprobe EP-23/26-LM-LT cont- Curved93/42 Endoprobe EP-23/26-LT cont. Curved93/42 Endoprobe EP-25-LT93/42 Gas-/Liquid Cooled Fiber3 refs LaEvita® Kit3 refs LITT 3B 1.8, IC LITT Fiber93/42 LITT Fiber 1.0, IC93/42 LITT Fiber 2.0, IC93/42 LITT Fiber 3.0, IC93/42 LITT Fiber 4.0, IC93/42 LITT2B 1.8, IC LITT Fiber93/42 Megabeam ENT-24-LM-LT-G Endoprobe93/42 Megabeam ENT-24-LT-G Endoprobe93/42 Orthopedic Fiber3 refs Orthopedic Kit3 refs Proctology3 refs Proctology Kit3 refs TULA® KIT3 refs Twister3 refs	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Diode surgical laser	Z12011016	Ceralas E 1470/15W/+-30nm/200µm93/42 Ceralas E 1470/15W/+-30nm/400µm93/42 Ceralas HPD 980/140W/+ 1470/60W/600µm93/42 Ceralas HPD 980/180W/+-30nm/400µm93/42 Ceralas HPD 980/300W/+-30nm/600µm93/42 17 others Leonardo®3 refs Leonardo® 106493/42 Leonardo® 180 Leonardo® HPD93/42 Leonardo® 980/30W93/42 Leonardo® 980/70W93/42 Leonardo® Bonsai Leonardo® Bonsai 147093/42 Leonardo® Bonsai 1470, Set Leonardo® DUAL 200 Leonardo® HPD93/42 Leonardo® Dual 4593/42 LEONARDO® HPD2 refs Leonardo® HPD, Set2 refs LEONARDO® Mini4 refs Leonardo® Mini 147093/42 Leonardo® Mini Blue93/42 Leonardo® Mini, Set3 refs Leonardo®, Set3 refs	IIb MDR, 93/42	EUDAMED record Report an error
Diode-pumped solid-state (dpss) surgical laser	Z12011006	Leonardo® Duster Leonardo® Duster, Set	IIb MDR	EUDAMED record Report an error
Infrared ultraviolet ray lamps	Z120614	beyondRED® PRO beyondRED® PRO, Set	IIb MDR	EUDAMED record Report an error
Laser surgery instruments - other	Z12011099	Bare Fiber, reusable, sterile3 refs Coupling Fiber2 refs	I, IIa MDR	EUDAMED record Report an error
Acupuncture stimulators	Z120623	Neurobeat® Applicator	IIa MDR	EUDAMED record Report an error
Laser surgery instruments - hardware accessories	Z12011080	ELVeS® smart2 refs	I MDR	EUDAMED record Report an error

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