510(k) K231997
- Device
- SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- Applicant
- Cure Point Therapeutics, Inc.
- 510(k) number
- K231997
- Product code
- ILY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-15
- Date received
- 2023-07-05
- Regulation
- 890.5500
- Classification name
- Lamp, Infrared, Therapeutic Heating
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Harold Kraft
- Address
- 1712 Pioneer Ave., Suite 2606 Cheyenne WY US 82001 82001
FDA Registration Numbers
- 3029083714
- 1055581
- 3031182687
- 3009765778
- 3030234143
- 3021743553
- 3035374386
- 3042371408
- 3016879560
- 3017618900
- 3030151584
- 3020659203
- 3018317166
- 3007674911
- 3006978331
- 3042269047
- 3010314781
- 3012184208
- 3018994966
- 3014158749
- 3008959444
- 3018608545
- 3042261334
- 3006475220
- 9612147
- 3034204485
- 3029950834
- 9616086
- 3019015047
- 3005515469
- 3008592814
- 3023344923
- 3016099060
- 3013178978
- 3012512142
- 3007689716
- 3004264602
- 3012386142
- 3011164092
- 3027327500
- 3044470839
- 3013591868
- 3011258423
- 3019623342
- 3029633864
- 3011249646
- 3040387923
- 3043165979
- 1055758
- 3023876581
- 3012327767
- 3013019295
- 3012657194
- 3014296246
- 3016071154
- 3011506263
- 3013052700
- 3026038437
- 3001431138
- 3030412027
- 3037013920
- 3010689958
- 3012147801
- 3023808059
- 3030498909
- 3042278987
- 3010280625
- 3012113199
- 3014386328
- 3037609256
- 3030508288
- 3015924074
- 3043661837
- 3003895865
- 3004505220
- 3033845665
- 3040389273
- 2087190
- 3013002868
Source Documents
510(k) summary PDF not indicated by FDA
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