510(k) K111454

Device: ILUMINAGE DIODE LASER
Applicant: CYNOSURE, INC.
510(k) number: K111454
Product code: OHS
Decision: Substantially Equivalent (SESE)
Decision date: 2012-07-05
Date received: 2011-05-25
Regulation: 878.4810
Classification name: Light Based Over The Counter Wrinkle Reduction
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: GEORGE CHO
Address: 5 Carlisle Rd. Wesford MA US 01886 01886

FDA Registration Numbers#

3022327202
3023371360
3019864920
3016055197
3013423303
3015109022
3017103444
3015415349
3012512142
3026890286
3015974280
3007689716
3009102830
3008929787
3023339103
3012657194
3039304811
3030234143
3015289316
3043749884
3042261413
3012470925
3043710338
3013178978
3022426824
3043165181
3019015047
3016071154
3033850491
3027651556
3010027944
3018259873
3029972385
3048610148
3013397886
3017422691
3017619615
3019577501
3012294783
3048086714
3044572954
3004126239
3013995763
3038319732
3016076077
3037031835
3037341611
3020900954
3016879560
1318319
3039443706
3012104022
3024892917
3007554929
3015168585
3004450661
3033793026
3015287734
3033847811
3029944286
3011564440
3013738756
3019887520
3018994966
3030194742
3015924074
3016171836
1832894
3017953405
3004167969
3014545271
3004839404
3015646995
3027645761
3044622318
3021282471
3038214786
9617486
3020659203

Source Documents#

Other 510(k) Records For Product Code OHS #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K260767	Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)	Kam Yuen Plastic Products , Ltd.	2026-08-31
K261602	Eye Recovery Pro (PH-e03)	Shenzhen Goodwind Technology Development Co., Ltd.	2026-08-10
K261601	LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)	Shenzhen Chuangtong Yigou Technology Co., Ltd.	2026-08-07
K261496	LED Light Therapy Masks (PE748, PE749, PE756)	Duplex International Trading Limited	2026-08-04
K261851	LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)	Shenzhen Qianyu Technology Co., Ltd.	2026-08-04
K261482	LightStim for Wrinkles (1984); LightStim for Acne (2038)	Led Intellectual Properties, LLC	2026-07-31
K260598	5 Wavelength LED Facemask (TN2508)	iSMART Developments, Ltd.	2026-07-24
K261407	XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)	Dongguan Miqiang Technology Co., Ltd.	2026-07-15
K261473	Chromix	Termosalud S.L.	2026-07-01
K261052	LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)	Guangdong Newdermo Biotech Co., Ltd.	2026-06-29
K260946	LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)	Guangdong Newdermo Biotech Co., Ltd.	2026-06-18
K254025	LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)	Shenzhen Kaiyan Medical Equipment Co., Ltd.	2026-06-16
K260715	CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)	The Beauty Tech Group, Ltd.	2026-06-03
K260415	myLEDmask 2 (MJ-144)	Light Tree Ventures Europe B.V.	2026-05-12
K260150	LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)	NOOANCE	2026-04-22

Legacy Summary#

summary

FDA Review#

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