510(k) K032460
- Device
- PROFILE BBL SYSTEM
- Applicant
- SCITON, INC.
- 510(k) number
- K032460
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-13
- Date received
- 2003-08-11
- 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
- No
Applicant Contact#
- Contact
- JAY M PATEL
- Address
- 845 Commercial St. Palo Alto CA US 94303 94303
FDA Registration Numbers#
- 3017144492
- 3038356864
- 3016096097
- 3017786046
- 3043153468
- 3007156625
- 1000523114
- 3002806603
- 3012294783
- 3007535734
- 2031934
- 3033126947
- 3019252665
- 2521877
- 1226005
- 3004497289
- 3006985163
- 3003610527
- 3030979014
- 9710340
- 1424785
- 3026400760
- 3004111573
- 3006786907
- 3044175602
- 2032092
- 3016830208
- 3010822033
- 2027755
- 3003288808
- 3011050570
- 3016170453
- 3014577013
- 3005282635
- 3027605646
- 3016413636
- 3042261306
- 3008085016
- 3006580954
- 3010363436
- 2938889
- 3042953831
- 3004361445
- 3002736133
- 3033274371
- 3025861981
- 2938071
- 3040278150
- 3008156177
- 3033273466
- 3004635398
- 3042351542
- 2916735
- 3015976667
- 2953696
- 3043654467
- 3009746061
- 3013503862
- 3021334828
- 3005581016
- 3011423170
- 3005238200
- 8010720
- 3007689716
- 3004069780
- 3043729119
- 3037047060
- 2032112
- 1644312
- 1000393132
- 1064858
- 3010281590
- 3043047259
- 3042255006
- 3008627763
- 3010220595
- 1221275
- 3016496662
- 2247224
Source Documents#
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262701 | PicoPeak Picosecond Nd:Yag Laser System (Bella-9) | Beijing Sea Heart International Science and Technologyco.Ltd | 2026-10-22 |
| K262628 | Picosecond Laser treatment system (Z180) | Sanhe PERFECTLASER Technology Co., Ltd. | 2026-10-20 |
| K261572 | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) | Keyue (Hangzhou) Medical Information Technology Co., Ltd. | 2026-10-13 |
| 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 |
Legacy Summary#
summary
FDA Review#
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