510(k) K203826
- Device
- LaserCap Family of Lasers 300, 224, 120 & 80
- Applicant
- Transdermal Cap, Inc.
- 510(k) number
- K203826
- Product code
- OAP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-29
- Date received
- 2020-12-29
- Regulation
- 890.5500
- Classification name
- Laser, Comb, Hair
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Michael Rabin
- Address
- 26 Alpha Park Highland Heights OH US 44143 44143
FDA Registration Numbers
- 3017422691
- 3015313684
- 3012512142
- 3015415349
- 3013387006
- 3025432379
- 3009765778
- 3014755446
- 3030234143
- 3042228064
- 3006182775
- 3008295459
- 3010724743
- 3018317166
- 3033847811
- 3015191560
- 3008855505
- 3010123655
- 3010309303
- 3016076077
- 3010162782
- 3043011436
- 3030220360
- 3014737458
- 3043140693
- 3010027944
- 3023339107
- 3011644607
- 3015249767
- 3009118729
- 3018949797
- 3016661372
- 3008393409
- 3012104022
- 3019015047
- 3012234230
- 3015060197
- 3023876581
- 3011258423
- 3012327767
- 3043012074
- 3017905264
- 3030265332
- 3013519365
- 3013553501
- 3013472744
- 3013503862
- 3006546131
- 3006206425
- 3015287734
- 3016245372
- 3010321647
- 3036498001
- 3043149902
- 3006985208
- 3014467408
- 2248223
- 3021349626
- 3043012240
- 3015086789
- 3038373471
- 3012541016
- 3020900954
- 3006368133
Source Documents
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| K242620 | Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. | 2024-11-01 |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. | 2024-10-11 |
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