510(k) K211517
- Device
- Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber La
- Applicant
- Convergent Laser Technologies
- 510(k) number
- K211517
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-09
- Date received
- 2021-05-17
- 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
- Jennifer Mok
- Address
- 1660 S. Loop Rd. Alameda CA US 94502 94502
FDA Registration Numbers#
- 3020611964
- 3016746323
- 2245304
- 3008720474
- 3011555967
- 3010511300
- 3015529593
- 3011743768
- 3005350457
- 3008729892
- 3031233199
- 3017400436
- 1313525
- 3010220595
- 3013734919
- 3012125201
- 3026400760
- 3007549439
- 1000391004
- 3043012074
- 3010359222
- 3012289707
- 3004884150
- 3012799115
- 2032513
- 3021550489
- 8030392
- 3014222368
- 8030115
- 3009039068
- 3017124433
- 3034246188
- 3005205318
- 3009593803
- 3018116888
- 3043127589
- 3012294783
- 1035236
- 3017065670
- 1319211
- 3005791808
- 3016170453
- 3016661372
- 1219930
- 1820334
- 1043653
- 3006247712
- 3011644607
- 3013121972
- 3005987567
- 2939653
- 2953684
- 3005282635
- 3006716777
- 3004940677
- 3027725665
- 3013557562
- 3010175098
- 3011657089
- 3031944951
- 3009746061
- 3034630389
- 3010933841
- 3005180774
- 3011024620
- 3006546131
- 3016076698
- 3008805497
- 3027619554
- 3009970070
- 3030418454
- 1216677
- 8043564
- 3016445722
- 3004378299
- 3016413636
- 3043729119
- 3013503862
- 3004642415
Source Documents#
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| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | 2026-03-31 |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | 2026-03-28 |