510(k) K250397
- Device
- Helios Dermal Scaffold
- Applicant
- Helios Biomedical, Inc.
- 510(k) number
- K250397
- Product code
- KGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-15
- Date received
- 2025-02-12
- Classification name
- Wound Dressing With Animal-Derived Material(S)
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Yiannis Monovoukas
- Address
- 11 Dellbrook Rd. Weston MA US 02493 02493
FDA Registration Numbers#
- 2032542
- 1648579
- 3009973323
- 1000393132
- 3011649314
- 3009504230
- 3010155661
- 3027448274
- 8043484
- 3010668881
- 3014820861
- 2245437
- 3016904853
- 3010894343
- 1720929
- 3014498807
- 3007735241
- 1646434
- 3015309358
- 3005433617
- 3015282703
- 3015058854
- 1645368
- 3010600625
- 3015980493
- 1066741
- 2530957
- 3004117927
- 3004713654
- 3012535730
- 1220477
- 1417592
- 3025316685
- 3014982332
- 2245304
- 3036710971
- 1225991
- 3015238043
- 3003636207
- 1649518
- 1060680
- 9680091
- 3002636527
- 3013012623
- 3008770963
- 3030067857
- 3017297225
- 3012823434
- 3009109670
- 3031600472
- 3013517171
- 8043396
- 1064858
- 2135152
- 1450662
- 3004189237
- 3031743608
- 3004431266
- 3015525200
- 3002907620
- 3013820501
- 1221816
- 2245539
- 3042617688
- 2530154
- 3014146451
- 3004170064
- 3003300673
- 3015946784
- 3042750477
- 3003768919
- 3031238659
- 2431866
- 3019356409
- 1650372
- 3008374791
- 1319660
- 1929833
- 3039592366
- 3008102042
Source Documents#
Other 510(k) Records For Product Code KGN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 2026-02-19 |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 2026-02-10 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 |
| K253339 | Theracor | Stimlabs, LLC | 2025-12-22 |
| K252673 | LacertaMatrix | Lacerta Life Science | 2025-12-22 |
| K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | 2025-12-19 |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | 2025-10-16 |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2025-10-10 |
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025-07-16 |
| K250329 | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | 2025-06-25 |