E-Light Line: FDA 510(k) K092734, Espansione Marketing S.P.A

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK092734	Date20 Sep 2010Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K092734

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K092734
FDA product code: GEX

Device class: Class II
Regulation: 21 CFR Part 878.4810
Advisory committee: General, Plastic Surgery
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Leda K090762 28 Aug 2009 FDA record · FDA summary
Photonova Family Of Pulsed Light Systems K073477 9 May 2008 FDA record
Epi-C Plus K070494 1 May 2007 FDA record
Illumimed K060792 1 Dec 2006 FDA record
Cellu M6 Keymodule I K053225 6 Nov 2006 FDA record
Revlight Skin Care System K042630 27 Jun 2005 FDA record
Gentlewaves Led Photomodulation Device K031425 15 Dec 2004 FDA record
Omnilux Red K030426 17 Jul 2003 FDA record
Omnilux Blue K030883 18 Jun 2003 FDA record

Cited by

Young Again K124064 19 Dec 2013 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K092734

30 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K092734
		UDI-DI	Size and differences
E-LIGHT LINE E-LIGHT DEVICE ESPANSIONE MARKETING SPA	E-LIGHT DEVICE / E-LIGHT DEVICE	08056389700019	—	No longer on the market
E-LIGHT LINE EPI-C PLUS ESPANSIONE MARKETING SPA	EPI-C PLUS / EPI-C PLUS	08056389701047	—	On the market
E-LIGHT LINE EPI-C PLUS/E/110V ESPANSIONE MARKETING SPA	EPI-C PLUS/E/110V / EPI-C PLUS/E/110V	08056389700101	—	On the market
E-LIGHT LINE IPL LAMP ESPANSIONE MARKETING SPA	IPL LAMP / IPL LAMP	08056389700125	—	On the market
E-LIGHT LINE IPL LAMP-05 ESPANSIONE MARKETING SPA	IPL LAMP-05 / IPL LAMP-05	08056389700149	—	On the market
E-LIGHT LINE IPL LAMP-20 ESPANSIONE MARKETING SPA	IPL LAMP-20 / IPL LAMP-20	08056389700163	—	On the market
E-LIGHT LINE IPL LAMP-390 ESPANSIONE MARKETING SPA	IPL LAMP-390 / IPL LAMP-390	08056389701009	—	On the market
E-LIGHT LINE IPL LAMP-550 ESPANSIONE MARKETING SPA	IPL LAMP-550 / IPL LAMP-550	08056389701016	—	On the market
E-LIGHT LINE IPL LAMP-DS ESPANSIONE MARKETING SPA	IPL LAMP-DS / IPL LAMP-DS	08056389701030	—	On the market
E-LIGHT LINE IPL LAMP-LS ESPANSIONE MARKETING SPA	IPL LAMP-LS / IPL LAMP-LS	08056389701023	—	On the market
E-LIGHT LINE LAMP570AC ESPANSIONE MARKETING SPA	LAMP570AC / LAMP570AC	08056389700712	—	On the market
E-LIGHT LINE LED MASK ESPANSIONE MARKETING SPA	LED MASK / LED MASK	08056389700118	—	No longer on the market
E-LIGHT LINE LED MASK H ESPANSIONE MARKETING SPA	LED MASK H / LED MASK H	08056389700071	—	On the market
E-LIGHT LINE LED MASK H-05/BLUE ESPANSIONE MARKETING SPA	LED MASK H-05/BLUE / LED MASK H-05/BLUE	08056389700446	—	On the market
E-LIGHT LINE LED MASK H-05/YELLOW ESPANSIONE MARKETING SPA	LED MASK H-05/YELLOW / LED MASK H-05/YELLOW	08056389701412	—	On the market
E-LIGHT LINE LED MASK H-20/BLUE ESPANSIONE MARKETING SPA	LED MASK H-20/BLUE / LED MASK H-20/BLUE	08056389700453	—	On the market
E-LIGHT LINE LED MASK H/BLUE ESPANSIONE MARKETING SPA	LED MASK H/BLUE / LED MASK H/BLUE	08056389700415	—	On the market
E-LIGHT LINE LED MASK H/YELLOW ESPANSIONE MARKETING SPA	LED MASK H/YELLOW / LED MASK H/YELLOW	08056389700422	—	On the market
E-LIGHT LINE LED MASK/BLUE-05 ESPANSIONE MARKETING SPA	LED MASK/BLUE-05 / LED MASK/BLUE-05	08056389700217	—	No longer on the market
E-LIGHT LINE LED MASK/RED-05 ESPANSIONE MARKETING SPA	LED MASK/RED-05 / LED MASK/RED-05	08056389700132	—	No longer on the market
E-LIGHT LINE LED MASK/RED-20 ESPANSIONE MARKETING SPA	LED MASK/RED-20 / LED MASK/RED-20	08056389700156	—	No longer on the market
E-LIGHT LINE LED MASK/YELLOW-05 ESPANSIONE MARKETING SPA	LED MASK/YELLOW-05 / LED MASK/YELLOW-05	08056389700200	—	On the market
E-LIGHT LINE LED MASKH-05 ESPANSIONE MARKETING SPA	LED MASK H-05 / LED MASKH-05	08056389700088	—	On the market
E-LIGHT LINE LED MASKH-20 ESPANSIONE MARKETING SPA	LED MASK H-20 / LED MASKH-20	08056389700095	—	No longer on the market
E-LIGHT LINE MASK LM BLUE/CE ESPANSIONE MARKETING SPA	MASK LM BLUE/CE / MASK LM BLUE/CE	08056389700187	—	No longer on the market
E-LIGHT LINE MASK LM BLUE/CE-0500 ESPANSIONE MARKETING SPA	MASK LM BLUE/CE-0500 / MASK LM BLUE/CE-0500	08056389701368	—	On the market
E-LIGHT LINE MASK LM RED/CE ESPANSIONE MARKETING SPA	MASK LM RED/CE / MASK LM RED/CE	08056389700170	—	No longer on the market
E-LIGHT LINE MASK LM RED/CE-0500 ESPANSIONE MARKETING SPA	MASK LM RED/CE-0500 / MASK LM RED/CE-0500	08056389701351	—	On the market
E-LIGHT LINE MASK LM YELLOW/CE ESPANSIONE MARKETING SPA	MASK LM YELLOW/CE / MASK LM YELLOW/CE	08056389700194	—	No longer on the market
E-LIGHT LINE MASK LM YELLOW/CE-0500 ESPANSIONE MARKETING SPA	MASK LM YELLOW/CE-0500 / MASK LM YELLOW/CE-0500	08056389701375	—	On the market

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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Young Again

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