Submission Details
| 510(k) Number | K221635 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 2022 |
| Decision Date | August 31, 2022 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
IPL sapphire ice cooling hair remove device
Aug 2022
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K221635 is an FDA 510(k) clearance for the IPL sapphire ice cooling hair remove device, a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Shenzhen Desida Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 31, 2022, 86 days after receiving the submission on June 6, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
Device Classification
| Product Code | OHT — Light Based Over-the-counter Hair Removal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal. |
Manufacturer
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