510(k) K252519
- Device
- CO2 Laser Therapy System (K106)
- Applicant
- Hebei Keylaser Sci-Tech Co.,Ltd
- 510(k) number
- K252519
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-07
- Date received
- 2025-08-11
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Zhen Yang
- Address
- 4th Floor Bldg. C18-2, Hegu Industry Park, Chaoyang E. Rd., Zhuozhou Baoding CN 072750 072750
FDA Registration Numbers
- 3038715747
- 1725006
- 3018116888
- 3013917867
- 3023344923
- 3030495752
- 1054713
- 3030233762
- 3011657089
- 3010060157
- 1221275
- 3012452798
- 3019906161
- 2438558
- 2183744
- 3020611964
- 2939653
- 3009039068
- 3030230686
- 3008805497
- 1216677
- 3005801723
- 3003610374
- 2938071
- 3032916575
- 1313525
- 3011050570
- 3003015433
- 3013376016
- 3015392301
- 3020770009
- 8044098
- 2027755
- 3009488834
- 3011302631
- 3008442971
- 1064858
- 1225072
- 3002807314
- 1045254
- 1419489
- 3017124433
- 3043011436
- 3030733800
- 3004378299
- 3013602304
- 8021543
- 8040564
- 3016453004
- 3007336385
- 3043047259
- 3009649442
- 1723170
- 1226486
- 3017200975
- 3011743768
- 3013041594
- 3006368133
- 3015313684
- 3029083714
- 3014561425
- 3036240802
- 3016413636
- 3008915316
- 3016170453
- 3021550489
- 3009298127
- 3014980477
- 3005210579
- 2032112
- 3016830208
- 2954354
- 3011670002
- 9610617
- 3034630389
- 3009462521
- 3008925277
- 2953684
- 3042261306
- 3012133441
- 1048735
- 3005581016
- 8030115
- 3016076698
- 2936921
- 3015907115
- 1318319
- 3006680097
- 2020550
- 1038823
- 8030987
- 3043127589
- 3033273466
- 3007689716
- 3044175602
- 3006546131
- 3004485166
- 3008872264
- 9680671
- 3008627763
- 8043792
- 3019252665
- 3007120647
- 3018094310
- 3004505220
- 3017125161
- 3012980277
- 3038356864
- 3015452693
- 1423662
- 2032092
- 3007674911
- 3008252121
- 3014737458
- 3020756
- 2938889
- 3005987567
- 3013404959
- 3011644607
- 3043657394
- 3022327202
- 9612448
- 3004858034
- 3005791808
- 3014226003
- 3006985208
- 3013557562
- 3031582430
- 3010202439
- 3004135191
- 3034995492
- 3012125201
- 9614977
- 3008965332
- 3001222017
- 3002991496
- 2521877
- 3005739661
- 3012157621
- 3006695864
- 3007549439
- 3003288808
- 3011423170
- 3037966040
- 3020221089
- 3033524191
- 9611036
- 3011782009
- 3011412640
- 3013446079
- 3004710757
- 1058584
- 3010175098
- 3033511105
- 3005282635
- 3004633032
- 3010683226
- 3031944951
- 3043153468
- 3027725665
- 3005180774
- 3033715699
- 2247224
- 3003082988
- 1000393132
- 3043012240
- 1221543
- 3012294783
- 3010822033
- 1319639
- 3017065670
- 3007583504
- 3015167792
- 3006786907
- 3004635398
- 1060848
- 1424785
- 3035375056
- 3015807001
- 3012639861
- 3025104654
- 9612147
- 1222773
- 3015077548
- 3021159346
- 3006849754
- 1647149
- 3010273872
- 3010627091
- 3015262665
- 3033884002
- 3007689729
- 3010902869
- 3013515803
- 3010314781
- 1419951
- 3003616071
- 3005730446
- 3004497289
- 3005238200
- 3010220595
- 3013697074
- 3010363436
- 3039396569
- 1222993
- 3017181358
- 3034246188
- 3042641021
- 3011024620
- 3009887511
- 3012772112
- 3030979156
- 3007181527
- 3024753061
- 3043012074
- 3014388884
- 3040278125
- 3042262496
- 3026360847
- 1000121056
- 3013529876
- 2011068
- 3014222368
- 1424263
- 3031233197
- 3020900954
- 3009970070
- 1000548922
- 3010972758
- 3009078366
- 3016181563
- 1032227
- 3023344928
- 3016076077
- 3002807636
- 3010273372
- 3004884150
- 8030885
- 3003610527
- 1037955
- 3002807715
- 3023343409
- 3017264244
- 3013503862
- 3014144061
- 3043149902
- 3043654467
- 3033126947
- 3015529593
- 1721676
- 3009040934
- 1820334
- 3037874486
- 9613462
- 3005099803
- 1035236
- 3003168101
- 3004361445
- 3008156177
- 3014225468
- 3010724743
- 2916735
- 3009453258
- 3010511300
- 3014253920
- 3010281590
- 3037047060
- 3027605646
- 3001605696
- 3004642415
- 3008393409
- 3017144492
- 3015433394
- 3018318562
- 3013619029
- 3033482500
- 3004940677
- 3015151147
- 3014577013
- 3015658550
- 3038189188
- 3014342096
- 3007085226
- 3015730775
- 1420032
- 3011964664
- 3012322232
- 3003340844
- 3011514163
- 3002808227
- 3021315370
- 8010720
- 3027851853
- 3010364538
- 3038197172
- 3005972890
- 3012236936
- 3005941719
- 3004374705
- 3006580954
- 2647580
- 3012289707
- 3010359222
- 3008085016
- 3016096097
- 3025379728
- 3006985163
- 3009736547
- 3007084556
- 3012911444
- 3021011208
- 3033905238
- 3038373471
- 9611388
- 3017060146
- 3016445722
- 3017786046
- 9681260
- 3018100038
- 2124215
- 3030543531
- 3008206114
- 3017929928
- 3004483538
- 3010933841
- 3042953831
- 3010027944
- 3026668625
- 1319211
- 2031934
- 3040278150
- 3002806603
- 3009746061
- 3006082230
- 3011137372
- 3010053203
- 2011171
- 3021334828
- 3016496662
- 3008720474
- 3006247712
- 3015976667
- 9615030
- 3008729892
- 3019559090
- 3007113239
- 1825146
- 3000313549
- 3011310540
- 3027605507
- 3013532143
- 3006515340
- 3030090167
- 3043140693
- 2953696
- 3006546082
- 3017954802
- 1644312
- 1018470
- 3025482817
- 3011555967
- 1043653
- 3005350457
- 2529392
- 2246552
- 3013121972
- 3030418454
- 9616684
- 2183911
- 3026294985
- 3029897009
- 3017173524
- 3012301874
- 3042228064
- 1018233
- 3009241253
- 3010035831
- 3005855240
- 1225450
- 3017638059
- 3006617841
- 3004167969
- 3033844600
- 3041275224
- 3009444646
- 2032513
- 3008776882
- 3007535734
- 3016661372
- 3012104022
- 3013613043
- 3026038437
- 9611516
- 9710340
- 3031233199
- 3006807694
- 1226005
- 3013789508
- 3011877721
- 3012440264
- 1928237
- 3003542872
- 3003899230
- 3030979014
- 3002736133
- 3014384451
- 3033274371
- 3003477135
- 3038372243
- 2245304
- 8043564
- 3009383334
- 3013734919
- 3030420005
- 3005695724
- 3015779311
- 3007048256
- 3005580113
- 3007156625
- 3005545844
- 3003708273
- 3026540840
- 3043729119
- 3016453096
- 3042255006
- 1000523114
- 3014310779
- 1220477
- 3009380063
- 3006555617
- 3003683459
- 3023808190
- 3012669557
- 3009593803
- 3010707607
- 3014980461
- 3026400760
- 3004096429
- 3017400436
- 2134812
- 3005515469
- 3003790304
- 3019705154
- 3006716777
- 3018188770
- 3005403788
- 2018957
- 3010912900
- 3001431138
- 3017132875
- 3009019578
- 3005205318
- 3016678045
- 3004529369
- 3032147807
- 3034456223
- 3004450661
- 3030125922
- 3004475754
- 3016405041
- 3012799115
- 3021380980
- 3017140525
- 3004069780
- 8010349
- 3016746323
- 8030392
- 3021349626
- 1219930
- 2528981
- 3007712511
- 1000391004
- 3025268687
- 2031763
- 3013397886
- 2125050
Source Documents
Other 510(k) Records For Product Code GEX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-05-07 |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2026-05-04 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | 2026-05-04 |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | 2026-04-29 |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | 2026-04-15 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | 2026-03-17 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | 2026-03-17 |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026-03-11 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2026-03-06 |