510(k) K925642
- Device
- ZEISS DIODE-PUMPED SOLID STATE LASER
- Applicant
- CARL ZEISS, INC.
- 510(k) number
- K925642
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-13
- Date received
- 1992-11-09
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER TALBOT
- Address
- 305 College Rd. E. Princeton NJ US 08540 08540
FDA Registration Numbers#
- 3006985163
- 3007731000
- 3010027944
- 3044175602
- 2938071
- 3017125161
- 3001222017
- 3003708273
- 3009380063
- 3006985208
- 3012452798
- 3010822033
- 3042261306
- 3016076698
- 2134812
- 3013121972
- 2011068
- 3007712511
- 3011137372
- 3034246188
- 3009462521
- 3011670002
- 3017144492
- 3004450661
- 1032227
- 3007085226
- 3033715699
- 3013404959
- 3012294783
- 1045254
- 9611388
- 3045892905
- 3008776882
- 3015392301
- 3014310779
- 1221543
- 3015452693
- 3044905918
- 3012669557
- 2032513
- 3026360847
- 8030392
- 3006546082
- 1820334
- 3017060146
- 3009241253
- 3025379728
- 3031944951
- 3011423170
- 3003899230
- 3004361445
- 3009453258
- 3012133441
- 3026668625
- 8040564
- 3014577013
- 3043012240
- 3004710757
- 3017124433
- 3023816720
- 3035375056
- 3011024620
- 3010902869
- 3008627763
- 3017140525
- 3005791808
- 3004111573
- 3003542872
- 9616684
- 2011171
- 3020756
- 8043792
- 3002736133
- 3002807636
- 2953696
- 3009488834
- 3022327202
- 3026294985
- 3012322232
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263063 | B`orze Inc Laser Family (Sorren/Adonis) | Borze, Inc. | 2026-10-30 |
| K262349 | Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI) | Risu Medical Technology Co., Ltd. | 2026-10-27 |
| K262627 | Fractional CO2 Laser Therapy System (Z121) | Sanhe PERFECTLASER Technology Co., Ltd. | 2026-10-26 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases