510(k) K242987
- Device
- Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- Applicant
- Allengers Global Healthcare Private Limited
- 510(k) number
- K242987
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-17
- Date received
- 2024-09-26
- 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
- No
Applicant Contact#
- Contact
- Harpreet Singh
- Address
- Rm. #5, Khasra # 79, Bhankarpur, Mubarakpur Rd. District- Mohali Derabassi IN 140507 140507
FDA Registration Numbers#
- 3022327202
- 3007731000
- 3009970070
- 3006427656
- 3043047259
- 3007549439
- 3007689716
- 3012799115
- 3004135191
- 3014226003
- 2011171
- 3004505220
- 3030979014
- 3003708273
- 3038715747
- 3015392301
- 1018233
- 3039080630
- 3011050570
- 3016181563
- 3025379728
- 3006985208
- 3037874486
- 3033524191
- 3026038437
- 3037047060
- 3031944951
- 3005238200
- 3004635398
- 3033126947
- 3030420005
- 3048506982
- 3033482500
- 3032147807
- 2031934
- 3004111573
- 3010627091
- 3015807001
- 1000548922
- 3021550489
- 3009746061
- 3012125201
- 3006368133
- 3012104022
- 3002736133
- 3030230686
- 8040564
- 1424263
- 3015262665
- 3015151147
- 3006515340
- 3015167792
- 3003082988
- 3008872264
- 3007120647
- 3007674911
- 3014225468
- 3034246188
- 2183911
- 3043127589
- 1226005
- 3038197172
- 3009649442
- 3013404959
- 1644312
- 3011670002
- 3006716777
- 3011423170
- 3021334828
- 3002808227
- 3014253920
- 3023816720
- 3008252121
- 3016496662
- 3008925277
- 3034630389
- 3030543531
- 3006247712
- 9681260
Source Documents#
Other 510(k) Records For Product Code GEX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262346 | CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5) | Wuhan Phomed Technology Co., Ltd. | 2026-10-08 |
| K261692 | Diode Laser Hair Removal Machine (QDTM-03) | Beijing Nubway S&T Co., Ltd. | 2026-10-07 |
| K254199 | PicoreMax (PicoreMax) | BLUECORE COMPANY Co., Ltd. | 2026-09-24 |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | 2026-09-19 |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | 2026-09-19 |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | 2026-09-18 |
| K261673 | LED Therapy Device (QLXY-01) | Beijing Nubway S&T Co., Ltd. | 2026-09-17 |
| K261817 | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-17 |
| K262877 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | 2026-09-16 |
| K261562 | Diode Laser Therapy System | Sanhe LEFIS Electronics Co., Ltd. | 2026-09-10 |
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | 2026-09-10 |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-09-02 |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | 2026-09-01 |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2026-08-27 |
| K261964 | ECHOLASER X4 | Elesta S.P.A | 2026-08-19 |