Manufacturer
Daeju Meditech Engineering Co., Ltd.AROMA GRAND
Daeju Meditech Engineering Co., Ltd.
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K211637
- Device name
- AROMA GRAND
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-05-27
- Decision date
- 2021-09-03
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatmentPigment treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Intended Use
The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece. The emission laser is activated by a footswitch.
Summary parsed at:2026-06-01 05:43:13 UTC
Predicate devices
1VIKINI Diode Laser System
K211637 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K211637 as a predicate